Company ยท DK
Radiometer Medical Aps
FDA 510(k) clearances and medical device recalls filed under this name, 2004 to 2017. Name variants (Inc, Corp, punctuation) are merged.
28510(k) clearances (0 in 12 months)
26recalls (1 in 12 months)
20recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| CHL | Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph | 28 |
| CEM | Electrode, Ion Specific, Potassium | 4 |
| GIO | Tube, Collection, Capillary Blood | 3 |
| JJS | Controls For Blood-Gases, (Assayed And Unassayed) | 3 |
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | 3 |
| LKD | Monitor, Carbon-Dioxide, Cutaneous | 3 |
| JHX | Fluorometric Method, Cpk Or Isoenzymes | 2 |
| MQM | Bilirubin (Total And Unbound) In The Neonate Test System | 2 |
| OUG | Medical Device Data System | 2 |
| CGL | Electrode, Ion Based, Enzymatic, Creatinine | 1 |
| CIG | Diazo Colorimetry, Bilirubin | 1 |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 |
| KHO | Fluorometer, For Clinical Use | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 21, 2017 | K163462 | AQT90 FLEX Myo Test Kit, AQT90 FLEX CKMB Test Kit, AQT90 FLEX Radiometer Medical Aps, DK | JHX |
| Apr 28, 2017 | K170882 | ABL90 FLEX, ABL90 FLEX PLUS Radiometer Medical Aps, DK | MQM |
| Nov 4, 2016 | K160153 | ABL90 FLEX PLUS Radiometer Medical Aps, DK | CHL |
| Jun 17, 2015 | K142898 | ABL800 FLEX with AQURE connectivity Radiometer Medical Aps, DK | CHL |
| May 13, 2015 | K150226 | Hematocrit and Metabolite QUALICHECK Radiometer Medical Aps, DK | JJS |
| Nov 13, 2014 | K132691 | ABL90 FLEX Radiometer Medical Aps, DK | MQM |
| Sep 17, 2013 | K131988 | ABL90 FLEX ANALYZER Radiometer Medical Aps, DK | CHL |
| Jul 31, 2013 | K130144 | ABL90 FLEX Radiometer Medical Aps, DK | CHL |
| May 7, 2013 | K123748 | ABL90 FLEX Radiometer Medical Aps, DK | CHL |
| Mar 26, 2013 | K130415 | HIGH METABOLITE QUALICHECK Radiometer Medical Aps, DK | JJS |
| Mar 15, 2013 | K130236 | RANGE + QUALICHECK LEVEL 1, RANGE + QUALICHECK LEVEL 2, RANGE + QUALICHECK LEVEL 3 Radiometer Medical Aps, DK | JJS |
| Nov 21, 2012 | K120326 | AQT90 FLEX CKMB TEST KIT, AQT90 FLEX LQC MULTI-CHECK, LEVELS 1-3, AQT90 FLEX CKMB CAL CARTRIDGE Radiometer Medical Aps, DK | JHX |
| Nov 16, 2012 | K122729 | ABL90 FLEX Radiometer Medical Aps, DK | CHL |
| Oct 26, 2012 | K122642 | ABL90 FLEX Radiometer Medical Aps, DK | CHL |
| Mar 19, 2012 | K120197 | ABL90 FLEX Radiometer Medical Aps, DK | CHL |
| Jan 20, 2012 | K112161 | AQT90 FLEX ANALYZER, AQT90 FLEX MYOGLOBIN TEST KIT, AQT90 FLEX LQC MULTI-CHECK, LVLS 1-3, AQT90 FLEX MYO CAL CARTRIDGE.. Radiometer Medical Aps, DK | KHO |
| Jul 19, 2011 | K111897 | ABL90 Radiometer Medical Aps, DK | CHL |
| Mar 24, 2011 | K110416 | ABL835 FLEX ANALYZER WITH PLEURAL PH Radiometer Medical Aps, DK | CHL |
| Dec 10, 2010 | K100777 | ABL837 FLEX ANALYZER Radiometer Medical Aps, DK | CHL |
| Aug 6, 2010 | K092686 | ABL90 FLEX SERIES Radiometer Medical Aps, DK | CEM |
| Feb 5, 2010 | K093154 | TCM TOSCA MONITORING SYSTEM, TCM COMBIM MONITORING SYSTEM Radiometer Medical Aps, DK | LKD |
| Oct 16, 2006 | K051968 | ABL8X7 FLEX Radiometer Medical Aps, DK | CGL |
| Oct 12, 2005 | K051928 | AUTOCHECK6+ Radiometer Medical Aps, DK | JJY |
| Aug 11, 2005 | K050869 | MODIFICATION TO ABL800 FLEX Radiometer Medical Aps | CIG |
| May 10, 2005 | K043218 | ABL800 FLEX WITH FLEXQ MODULE, MODEL ABL8XX Radiometer Medical Aps, DK | CHL |
| Apr 22, 2005 | K043143 | SAFEPICO Radiometer Medical Aps, DK | JKA |
| Mar 1, 2005 | K043003 | TCM40 MONITORING SYSTEM Radiometer Medical Aps, DK | LKD |
| Oct 8, 2004 | K041874 | ABL800 FLEX Radiometer Medical Aps, DK | CHL |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 15, 2026 | Radiometer Medical ApS The ABL90 FLEX and ABL90 FLEX PLUS analyzers are intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient or point Open, Classified |
CHL | K041874 |
| Apr 23, 2025 | Radiometer Medical ApS Radiometer ABL90 Series - Radiometer ABL90 FLEX Model Number 393-090
Radiometer ABL90 Series - Radiometer ABL90 FLEX PLUS Model Number 393-092
The Radiometer ABL90 Series is a portable, automated an Open, Classified |
CHL | K092686 K160153 |
| Jul 24, 2024 | Radiometer Medical ApS ABL800 FLEX
Model Numbers 393-800 and 393-801
The ABL800 FLEX analyzers are intended for:
" In Vitro testing of samples of whole blood for the parameters pH, pO2, pCO2, cK+, cNa+, cCa2+, cCl , cGlu, Open, Classified |
CHL | K041874 |
| Apr 17, 2023 | Radiometer Medical ApS AQURE REF 933-599
Software Versions
2.5.2
2.5.3
2.5.4
2.6.0
2.6.1
The AQURE system is intended to let you manage analytical devices and operator profiles.
The user can associate patient data with tes Open, Classified |
OUG | None listed |
| May 18, 2022 | Radiometer Medical ApS ABL800 Flex Analyzer Model Numbers 393-800 and 393-801 Open, Classified |
CHL | K041874 |
| Apr 8, 2022 | Radiometer Medical ApS Radiometer, REF:956-552, PIC050- Arterial Blood Sampler 1 X 2 mL, 80 IU electrolyte-balanced heparin. Not for injection. , IVD, Rx Only, Sterile EO, CE Open, Classified |
JKA | K962158 |
| Apr 14, 2021 | Radiometer Medical ApS E3800 PC Units (spare parts) Open, Classified |
CEM | K092686 K160153 |
| Apr 14, 2021 | Radiometer Medical ApS Radiometer ABL90 FLEX PLUS Analyzer with E3800 PC units.
The E3800 CPU is also used as spare part. Open, Classified |
CHL | K160153 |
| Apr 14, 2021 | Radiometer Medical ApS Radiometer ABL90 FLEX Analyzer with E3800 PC units.
The E3800 CPU is also used as spare part. Open, Classified |
CEM | K092686 |
| Mar 26, 2021 | Radiometer Medical ApS PIC070 Arterial Blood Sampler PICO70 - Product Usage: Preheparinized, electrolyte-balanced, arterial blood sampler product line for collection of arterial samples for pH, blood gas, oximetry, electrol Terminated |
JKA | None listed |
| May 26, 2020 | Radiometer Medical ApS Blood gases (PCO2, PO2) and blood pH test system; ABL800 FLEX; Model Number 393-801; UDI (01)05700693938011. Model 393-801 is available as ABL837. The FlexQ module is optional and can be added to all Terminated |
CHL | K041874 |
| May 26, 2020 | Radiometer Medical ApS Blood gases (PCO2, PO2) and blood pH test system; ABL800 FLEX; Model Number 393-800; UDI (01)05700693938004. Model 393-800 is available in the following configurations: ABL835, ABL830, ABL827, ABL825, Terminated |
CHL | K041874 |
| May 11, 2020 | Radiometer Medical ApS ABL80-FLEX CO-OX 393-841 Box Label, REF 393-841, IVD, CE, UDI: 05700693938417 - Product Usage: It is intended for use in a laboratory environment, near patient or point-of-care setting. Terminated |
CHL | K080370 |
| May 11, 2020 | Radiometer Medical ApS ABL80-FLEX-393-839 Box Label, REF 393-839, IVD, CE, UDI: 05700693938394 - Product Usage: It is intended for use in a laboratory environment, near patient or point-of-care setting. Terminated |
CHL | K051804 |
| Mar 17, 2020 | Radiometer Medical ApS safeCLINITUBES Blood Sampler;REF 942-969;D957P-70-45x1 Terminated |
GIO | None listed |
| Mar 17, 2020 | Radiometer Medical ApS safeCLINITUBES Blood Sampler;REF 942-898;D957P-70-70x1 Terminated |
GIO | None listed |
| Mar 17, 2020 | Radiometer Medical ApS safeCLINITUBES Blood Sampler;REF 942-892;D957P-70-100x1 Terminated |
GIO | None listed |
| Mar 10, 2020 | Radiometer Medical ApS ABL800 FLEX, model number/UDI 393-800/0570 In Vitro testing of samples of whole blood for the parameters pH, pO2, pCO2, cK+, cNa+, cCa2+, cCl , cGlu, cLac, cCrea, ctBil, and co-oximetry parameters (c Terminated |
CHL | K041874 |
| Mar 6, 2020 | Radiometer Medical ApS ABL800 FLEX model number 393-800 and 393-801, UDI:(01)05700693938004 Open, Classified |
CHL | K041874 |
| Feb 20, 2020 | Radiometer Medical ApS TCM4 Base unit, Ref 391-880, UDI:(01)05700693918808, used with the monitor modules TCM4 (902-778), TCM40 (902-778, 902-946 or 902-862), TCM400 (902-564), TOSCA (903-044) and CombiM (903-111) - Product Terminated |
LKD | K001866 K043003 +1 |
| Feb 3, 2020 | Radiometer Medical ApS ABL90 FLEX PLUS Analyzer, Model Number 393-092 - Product Usage: It is intended for use in a laboratory environment, near patient or point-of-care setting. Terminated |
CHL | K160153 |
| Feb 3, 2020 | Radiometer Medical ApS ABL90 FLEX Analyzer, Model Numbers 393-090, with software versions below 3.4MR2 - Product Usage: It is intended for use in a laboratory environment, near patient or point-of-care setting. Terminated |
CEM | K092686 |
| Nov 21, 2019 | Radiometer Medical ApS ABL90 FLEX, model no. 393-090; and Spare Part Hemolyzer Units (902-980): R0526 - R0941 - Product Usage: are intended for use by trained technologists, nurses, physicians and therapists. It is intende Terminated |
CHL | K092686 |
| Nov 21, 2019 | Radiometer Medical ApS ABL90 FLEX PLUS, model no. 393-02; and Spare Part Hemolyzer Units (902-980): R0526 - R0941 - Product Usage: are intended for use by trained technologists, nurses, physicians and therapists. It is inte Terminated |
CHL | K160153 |
| Aug 8, 2019 | Radiometer Medical ApS AQURE basic sytem, FLEXLINK, REF 933-599, Version: 2.3.3 (17), CE IVD, Rx Only, UDI: (01)05700699335999
Intended use: The AQURE system is intended to let you manage analytical devices and operator p Terminated |
OUG | None listed |
| Mar 14, 2018 | Radiometer Medical ApS AQURE, Software version 2.3.0 and 2.3.1
Product Usage:
The AQURE system is intended to let allow the management of analytical devices and operator profiles. The user can associate patient data with t Terminated |
CHL | K130144 K142898 +1 |