Company ยท US
Radiometer America Inc
FDA 510(k) clearances and medical device recalls filed under this name, 1983 to 2016. Name variants (Inc, Corp, punctuation) are merged.
50510(k) clearances (0 in 12 months)
64recalls (0 in 12 months)
53recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| CHL | Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph | 45 |
| JJS | Controls For Blood-Gases, (Assayed And Unassayed) | 10 |
| JWY | Manual Antimicrobial Susceptibility Test Systems | 5 |
| CEM | Electrode, Ion Specific, Potassium | 4 |
| GIO | Tube, Collection, Capillary Blood | 4 |
| JFP | Electrode, Ion Specific, Calcium | 4 |
| LKD | Monitor, Carbon-Dioxide, Cutaneous | 4 |
| CGL | Electrode, Ion Based, Enzymatic, Creatinine | 3 |
| JGS | Electrode, Ion Specific, Sodium | 3 |
| JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 3 |
| JQP | Calculator/Data Processing Module, For Clinical Use | 3 |
| KLK | Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia | 3 |
| CGA | Glucose Oxidase, Glucose | 2 |
| DQA | Oximeter | 2 |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 2 |
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | 2 |
| CBT | Arterial Blood Sampling Kit | 1 |
| CGZ | Electrode, Ion-Specific, Chloride | 1 |
| GHS | Assay, Carboxyhemoglobin | 1 |
| GIM | Tubes, Vacuum Sample, With Anticoagulant | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 28, 2016 | K153712 | VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Verification Kit, VK-Crea Verification Kit Radiometer America, Inc. | JJY |
| Jan 10, 2000 | K992859 | ABL700 SERIES ANALYZER WITH AUTOCHECK MODULE Radiometer America, Inc. | CHL |
| Nov 24, 1999 | K991417 | ABL 735 ANALYZER Radiometer America, Inc. | CHL |
| Jan 6, 1999 | K982928 | NPT7 SERIES PH/BLOOD GAS AND CO-OXIMETRY SYSTEM Radiometer America, Inc. | CHL |
| Feb 9, 1998 | K980130 | ABL700 SERIES BLOOD GAS , CO-OXIMETRY, ELECTROLYTE & METABOLITE SYSTEM Radiometer America, Inc. | CHL |
| Jan 28, 1998 | K980135 | QUALICHECK5+ MODELS S7730, S7740, S7750, S7760 Radiometer America, Inc. | JJS |
| Jan 16, 1998 | K974818 | ABL555 BLOOD GAS, ELECTROLYTE & METABOLITE SYSTEM Radiometer America, Inc. | MMI |
| Oct 6, 1997 | K973367 | ABL555 BLOOD GAS, ELECTROLYTE & METABOLITE SYSTEM Radiometer America, Inc. | CHL |
| Oct 29, 1996 | K962158 | PICO MODELS 30, 50, 70 Radiometer America, Inc. | JKA |
| Oct 24, 1996 | K962334 | EML105 ELECTROLYTE METABOLITE ANALYZER Radiometer America, Inc. | JGS |
| Jun 14, 1996 | K961355 | MULTICHECK Radiometer America, Inc. | JJS |
| Jun 14, 1996 | K961354 | QUALICHECK 4 METABOLITE(S3630,S3640,S3650,S3660) Radiometer America, Inc. | JJS |
| Feb 20, 1996 | K952725 | MULTICHECK Radiometer America, Inc. | GLY |
| Nov 9, 1995 | K954612 | ABL SYSTEM 625, 615, 605 Radiometer America, Inc. | CHL |
| Oct 17, 1995 | K952621 | EML105 ELECTROLYTE METABOLITE ANALYZER Radiometer America, Inc. | CGA |
| Oct 7, 1995 | K951241 | HAEMOPHILUS/PNEUMOCOCCUS MIC PLATE Radiometer America, Inc. | JWY |
| Oct 7, 1995 | K951240 | JUSTONE Radiometer America, Inc. | JWY |
| Sep 5, 1995 | K952637 | QUALICHECK 4 GLUCOSE Radiometer America, Inc. | JJS |
| Jul 13, 1995 | K936305 | SENSITITRE/PIP/TA2 SUSCEPTIBILITY PLATES Radiometer America, Inc. | JWY |
| Mar 10, 1995 | K943882 | ABL5 BLOOD GAS SYSTEM;BPH5 BLOOD PH SYSTEM Radiometer America, Inc. | CHL |
| Feb 24, 1995 | K944753 | SENSITITRE SUSCEPTIBILITY ENTEROCOCCAL VANCO AMP Radiometer America, Inc. | JWY |
| May 27, 1994 | K935655 | ABL5 BLOOD GAS SYSTEM Radiometer America, Inc. | CHL |
| May 27, 1994 | K935121 | ABL SYSTEM 620 Radiometer America, Inc. | CHL |
| Apr 26, 1994 | K935515 | MULTICHECK(TM) Radiometer America, Inc. | JJS |
| Apr 26, 1994 | K935120 | EML 100 Radiometer America, Inc. | JGS |
| Mar 29, 1994 | K935566 | SENSI-CAL AMCO AEPA-1 Radiometer America, Inc. | LIE |
| Mar 9, 1993 | K924802 | CALIBRATION VERIFICATION KIT OR CVK Radiometer America, Inc. | JJY |
| Mar 9, 1993 | K923045 | SENSITITRE SUSCEPTIBILITY PLATES Radiometer America, Inc. | JWY |
| Sep 22, 1992 | K923342 | MICROBACT SOLID PLATE SYSTEMS Radiometer America, Inc. | JJS |
| Aug 28, 1992 | K922922 | ABL50 BLOOD GAS SYSTEM Radiometer America, Inc. | CHL |
| Feb 18, 1992 | K912444 | MICROBACT 12A SYSTEM, 12B SYSTEM, AND 24E SYSTEM Radiometer America, Inc. | LGM |
| Jan 28, 1992 | K914166 | ABL505 BLOOD GAS & ELECTROLYTE SYSTEM Radiometer America, Inc. | CHL |
| Jan 2, 1992 | K915399 | QUALICHECK 4 Radiometer America, Inc. | JJS |
| Jul 9, 1991 | K910827 | ABL520 BLOOD GAS SYSTEM Radiometer America, Inc. | GHS |
| Dec 13, 1990 | K904513 | ABL510 BLOOD GAS SYSTEM Radiometer America, Inc. | CHL |
| Nov 2, 1990 | K904733 | QUALICHECK 3 Radiometer America, Inc. | JJS |
| Apr 16, 1990 | K900333 | E5280 COMBINED TRANSCUTANEOUS TCP02/TCPCO2 ELECT. Radiometer America, Inc. | LKD |
| Jan 23, 1990 | K896514 | QS90 SMOOTH E ARTERIAL BLOOD SAMPLER Radiometer America, Inc. | GIM |
| Oct 6, 1989 | K895181 | ABL500 BLOOD GAS SYSTEM Radiometer America, Inc. | CHL |
| Sep 5, 1989 | K893587 | OXIMETER Radiometer America, Inc. | DQA |
| Aug 31, 1989 | K894776 | SENSITITRE INDOLE REAGENT Radiometer America, Inc. | JSS |
| Aug 3, 1989 | K894110 | QUALICHECK 2 Radiometer America, Inc. | JJS |
| Jun 9, 1989 | K890057 | SENSITITRE AUTO ID PLATE AP80 Radiometer America, Inc. | LQM |
| Jun 8, 1987 | K871353 | OXIMETER Radiometer America, Inc. | DQA |
| Mar 5, 1986 | K860057 | ABL330 ACID BASE LABORATORY Radiometer America, Inc. | CHL |
| Dec 30, 1985 | K853990 | OSM3 HEMOXIMETER Radiometer America, Inc. | JKS |
| Dec 10, 1984 | K844295 | ABL300 ACID BASE LABORATORY Radiometer America, Inc. | CHL |
| Jan 18, 1984 | K833696 | ACID BASE LABORATORY ABL4 Radiometer America, Inc. | CEM |
| May 18, 1983 | K831034 | QUALISTICK ARTERIAL BLOOD SAMPLER Radiometer America, Inc. | CBT |
| Apr 8, 1983 | K830805 | KNAI SODIUM POTASSIUM ANALYZER Radiometer America, Inc. | JSG |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 22, 2019 | Radiometer America Inc ABL90 FLEX Analyzer REF 393090 UDI:05700693930909 Terminated |
CEM | K092686 |
| Jul 3, 2018 | Radiometer America Inc ABL800 analyzer, model numbers 393-800 and 393-801. Terminated |
CHL | K041874 |
| Jul 2, 2018 | Radiometer America Inc Product: ABL800 FLEX with Crea. The ABL800 with Crea is available in the following configurations: ABL817, ABL827 and ABL837.
ABL800 Series Ref. 393-803, 393-804, 393-805, 393-806, 393-820, 393-821, Terminated |
CHL | K051968 |
| May 25, 2018 | Radiometer America Inc ABL90 FLEX analyzers with software versions 3.3MR1 or below. The ABL90 FLEX Analyzer is a portable, automated Analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin and oxim Terminated |
JJE | K120197 |
| Oct 24, 2017 | Radiometer America Inc ABL800 analyzer with FLEXQ module.
Device intended for in vitro testing of samples of whole blood for the parameters pCO2, cK+, cNa+, cCa2+, cCl , cGlu, cLac, cCrea, ctBil, and co-oximetry parameters Terminated |
CHL | K041874 |
| Sep 7, 2017 | Radiometer America Inc AutoCheck5+, Level 2, specifically designed for Radiometer Americas blood gas analyzers
The QUALICHECK+ quality control (QC) ampoules are specifically designed for Radiometer America s blood gas anal Terminated |
JJS | K980135 |
| Jan 26, 2017 | Radiometer America Inc The ABL800 Model#:All Terminated |
CHL | K041874 |
| Jan 26, 2017 | Radiometer America Inc ABL90 Flex
Model #: 393-090
Portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin, and oximetry in whole blood. Terminated |
CHL | K092686 |
| Dec 22, 2016 | Radiometer America Inc AQURE System
Software Version 2.2.0
Model #: 933-599
UDI: (01)05700699335999(10)2.2.0
Catalog number: 933-599
The AQURE system manages Radiometer blood gas and immunoassay analyzers and results from Terminated |
CHL | K130144 K142898 +1 |
| Feb 3, 2016 | Radiometer America Inc AQURE System; Model Number: 933-599. The AQURE System manages blood gas and immunoassay analyzers. Terminated |
CHL | K130144 K142898 +1 |
| Nov 18, 2015 | Radiometer America Inc TCM CombiM
Modules 903-111 Terminated |
LKD | K093154 |
| Aug 19, 2015 | Radiometer America Inc Radiometer Fixation Kit N20 for the TCM CombiM monitoring system, REF 905-873. The Fixation Kit N20 is used to apply tc Sensor 84 and tc Sensor 54 on the skin of a patient. TC sensor 84 and 54 are Terminated |
LKD | K093154 |
| Mar 18, 2015 | Radiometer America Inc Crea A and B membranes, packaged 4 per box
Used in conjunction with the ABL800 FLEX analyzers which are intended for: In Vitro Testing of samples of whole blood for the parameters pCO2, cK+,cNa+, cCa2 Terminated |
CGL | K051968 |
| Feb 9, 2015 | Radiometer America Inc ABL90 FLEX analyzer; Model number 393-090. A portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin and oximetry in whole blood. Terminated |
JJE | K120197 |
| Dec 24, 2014 | Radiometer America Inc HemoCue Glucose 201 Microcuvettes, The HemoCue Glucose 201 Microcuvettes are designed for use with the HemoCue Glucose 201Analyzer and the HemoCue Glucose 201 DM Analyzer (hereafter referred to as the Terminated |
CGA | K020935 |
| Sep 6, 2014 | Radiometer America Inc RADIANCE v. 2.4X, 2.5X and 2.6X
Product Usage: RADIANCE is a data processing application for clinical use intended to monitor, collect, store, retrieve and process laboratory data. RADIANCE is also Terminated |
JQP | None listed |
| Feb 24, 2014 | Radiometer America Inc pCO2 D788 Membranes. Distributed by Radiometer America, Inc., Westlake, OH.
An automatic or semi-automatic instrument used to identify and quantify two or more gases, and sometimes electrolytes, in w Terminated |
CHL | K041874 K980130 |
| Jan 23, 2014 | Radiometer America Inc ABL90 FLEX Analyzer Radiometer Medical ApS, kandevej 21
Brnshj, Denmark
A portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin and oximetry in whole b Terminated |
JGS | K092686 |
| Jan 10, 2014 | Radiometer America Inc pO2 D999 membrane units. Distributed by Radiometer America, Inc., Westlake, OH 44145
pO2 membrane units, ordering number 942-042 Intended use is in vitro testing of samples of whole blood for pO2 (par Terminated |
CHL | K895181 K922922 +1 |
| Sep 30, 2013 | Radiometer America Inc Lactate Membrane units for E7077 Electrode Radiometer Medical ApS. The intended use is in vitro testing of samples of whole blood. Terminated |
KHP | K002290 K043218 |
| Aug 8, 2013 | Radiometer America Inc TCM4 series Base Units, and spare part Power Supply, Radiometer Medical ApS, Akandevej 21, Brnshj, Denmark, www.radiometer.com. The devices are intended for continuous monitoring of carbon dioxide and Terminated |
LPP | K001866 K043003 |
| Dec 21, 2012 | Radiometer America Inc Qualicheck 1+, Aqueous Quality Control, Level 2, S7140, REF 944-042.
The solution is used for quality check of blood gas analyzers. Terminated |
JJE | K771444 |
| Aug 8, 2012 | Radiometer America Inc ABL90 FLEX software version 2.7 MR3.
The ABL90 FLEX analyzer is intended for in vitro testing of samples of heparinized whole blood. Terminated |
CHL | K120197 |
| Aug 8, 2012 | Radiometer America Inc The ABL software version 6.12 for the ABL800 and ABL700 analyzer. The analyzers are intended for the in Vitro testing of:
-Samples of whole blood for the parameters pH, pO2, pCO2,
cK+, cNa+, cCa2+, c Terminated |
CHL | K002290 K041874 +4 |
| Aug 8, 2012 | Radiometer America Inc The ABL software version 6.12 for the ABL800 analyzer. The analyzers are intended for the in Vitro testing of:
-Samples of whole blood for the parameters pH, pO2, pCO2,
cK+, cNa+, cCa2+, cCl, cGlu, c Terminated |
CHL | K002290 K041874 +4 |
| Feb 13, 2012 | Radiometer America Inc S1827 Crea Calibration solution 1, 944-135, Lot DV-02 Radiometer Medical, Bronshoj Denmark
Product Usage:
The S1827 Crea Calibration Solution 1 (944-135) Lot DV-02 is a solution used by the ABL 8x7 s Terminated |
CGL | K051968 |
| Dec 1, 2011 | Radiometer America Inc TC pCO2 Electrodes, Model/Part #945-655-E5260, 510(k) #K043003.
Product Usage: The device is intended for used with the firm's TCM series monitor. The E260mpCO2 electrode is a non-invasive devi Terminated |
LKD | K043003 |
| Jun 16, 2011 | Radiometer America Inc Ca++ Membrane Units, Model #942-046, and Model #942-060 used on ABL505/555, EML105, ABL600, ABL700 Series, and ABL800 Analyzers. The membranes are packaged in a plastic box which contains four (4) me Terminated |
JFP | K043218 K914166 +4 |
| Apr 28, 2011 | Radiometer America Inc ABL90 FLEX Portable Blood Gas Analyzer System, Part Number: 393-090, 510 (k) #K092686. All units equipped with software versions: 2.4.1680.25 and all previous versions are subject to recall.
The Terminated |
CEM | K092686 |
| Feb 2, 2011 | Radiometer America Inc ABL90 FLEX Blood Analyzer Part Number: 393-090.
Intended for use by trained technologists, nurses, physicians and therapists and for use in a laboratory environment, near patient or point-of-care se Terminated |
CEM | K092686 |
| Mar 5, 2010 | Radiometer America Inc Reference Electrode Membranes for use with blood gas analyzer ABL 800 FLEX, when used on ABL 827 and ABL 837 with Creatinine modules (8x7). The device is packaged four (4) units per box. Terminated |
CGL | K051968 |
| Jul 15, 2009 | Radiometer America Inc Waste bottles Part Numbers/Article Numbers: 905-590/D512 and 905-802/D513.
The waste bottles are used to collect waste from the ABL7XX and the ABL8XX blood gas analyzer after rinsing. Terminated |
CHL | K002290 K041874 |
| Dec 3, 2008 | Radiometer America Inc ABL7XX Calibration 1 Solution S1720. P/N S1720, 944-024
Intended for in vitro testing of samples of whole blood for the parameters pH, pO2, pCO2, potassium, sodium, calcium, chloride, glucose, lacta Terminated |
JFP | K002290 |
| Jan 18, 2008 | Radiometer America Inc ABL800 FLEX Series Analyzer - Human Blood Analyzer (Laboratory Device) Terminated |
CHL | K041874 |
| Jan 18, 2008 | Radiometer America Inc ABL700 Series analyzer - Human Blood Analyzer (Laboratory Device). Terminated |
CHL | K002290 |
| Oct 11, 2007 | Radiometer America Inc Pump waste tube for blood gas analysis kit. One yellowish/white rubber tube per plastic bag. Used on ABL800 Flex Series blood gas analyzers. Terminated |
CHL | K041874 |
| Jul 24, 2007 | Radiometer America Inc ABL 800 FLEX series blood gas analyzers containing software version 5.24. Terminated |
CHL | K041874 |
| Jul 24, 2007 | Radiometer America Inc ABL 700 Series blood gas analyzers equipped with Software Version 3.833. Terminated |
CHL | K002290 |
| Jul 3, 2007 | Radiometer America Inc SafeClinitubes, REF 942-892, D957P-70-100x1, contained in kits containing 250 SafeClinitubes, insert, mixing wires and end caps. Capillary samplers for drawing small amounts of blood for blood gas a Terminated |
GIO | None listed |
| Apr 6, 2007 | Radiometer America Inc ABL800 FLEX Series analyzer with FLEXQ module-equipped with software version 5.2 to 5.27 Terminated |
CHL | K043218 |
| Oct 28, 2006 | Radiometer America Inc Radiance Data Management System, Software Version 2.60, modification for the ABL800 Flex Blood Gas Analyzer Terminated |
JQP | K050869 |
| Aug 31, 2006 | Radiometer America Inc D826 Accessory kit for single tcpO2 Electrodes for use with the TCM400 Transcutaneous Monitor (Cutaneous Oxygen Monitor) Terminated |
KLK | K001866 |
| Aug 30, 2006 | Radiometer America Inc TC Monitor - Transcutaneous Monitor for p02 and pC02, Model #TCM4, (Cutaneous Oxygen Monitor) Terminated |
KLK | None listed |
| Aug 29, 2006 | Radiometer America Inc SafePICO Samplers, self-filling arterial blood samplers. The syringe blood samplers are individually packed in plastic pouches and distributed in cartons. Each carton contains ten (10) boxes and eac Terminated |
JKA | K043143 |
| Aug 29, 2006 | Radiometer America Inc TCM4 Series Monitoring System (Base Unit) 391-876 (affected device) CompactFlash cards: 914-698 (Defective Device Component) Terminated |
KLK | None listed |
| Aug 29, 2006 | Radiometer America Inc S1730 Calibration Solution 2, 200 mL, packed in single unit plastic bottles, REF 944-025, used with ABL700 Series Blood Gas Analyzers. Terminated |
CHL | None listed |
| Aug 26, 2006 | Radiometer America Inc SafeClinitubes, Capillary caps (purple), 905-787. The defective capillary caps may be included in capillary tube kits as follows: Clinitubes Kits: 942-890 (D941P-240-85x1), Lot Code: R0048; Clinit Terminated |
GIO | None listed |
| Aug 26, 2006 | Radiometer America Inc D7120, BG-OX Cartridge, D7120 REF 946-003, and 946-001, cuvettes for the NPT7 series of blood gas analyzers. Terminated |
CHL | K982928 |
| Aug 10, 2006 | Radiometer America Inc Blood Gas and Co-Ox Electrolyte & Metabolyte Analyzers, ABL-800 series, manufactured from 8/2004 through 9/2005. Terminated |
JFP | K041874 |
| Aug 10, 2006 | Radiometer America Inc Blood Gas and Co-Ox2 Electrolyte & Metabolyte Analyzers, ABL-700 Series, manufactured from 8/1998 through 11/2004. Terminated |
JFP | K002290 K980130 +2 |
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