Company ยท US
Draeger Medical, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1977 to 2014. Name variants (Inc, Corp, punctuation) are merged.
94510(k) clearances (0 in 12 months)
103recalls (0 in 12 months)
62recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| BSZ | Gas-Machine, Anesthesia | 60 |
| CBK | Ventilator, Continuous, Facility Use | 40 |
| CAI | Circuit, Breathing (W Connector, Adaptor, Y Piece) | 14 |
| OFP | Anesthesia Breathing Circuit Kit (Adult & Pediatric) | 13 |
| CAD | Vaporizer, Anesthesia, Non-Heated | 8 |
| BZO | Set, Tubing And Support, Ventilator (W Harness) | 7 |
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | 7 |
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | 6 |
| BYE | Attachment, Breathing, Positive End Expiratory Pressure | 4 |
| FMZ | Incubator, Neonatal | 4 |
| CAP | Monitor, Airway Pressure (Includes Gauge And/Or Alarm) | 3 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 3 |
| FTD | Lamp, Surgical | 3 |
| BTC | Bag, Reservoir | 2 |
| CAH | Filter, Bacterial, Breathing-Circuit | 2 |
| CBN | Apparatus, Gas-Scavenging | 2 |
| FLL | Continuous Measurement Thermometer | 2 |
| FMT | Warmer, Infant Radiant | 2 |
| BTI | Compressor, Air, Portable | 1 |
| BTT | Humidifier, Respiratory Gas, (Direct Patient Interface) | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 8, 2014 | K121886 | SAVINA 300 SAVINA 300, COUNTRY VARIANTS Draeger Medical GmbH | CBK |
| Jun 20, 2014 | K133886 | PERSEUS A500 Draeger Medical GmbH | BSZ |
| Feb 28, 2013 | K121999 | GENERAL PURPOSE TEMPERATURE PROBE, SKIN TEMPERATURE PROBE Draeger Medical GmbH | FLL |
| Mar 28, 2012 | K103035 | SMARTPILOT VIEW MODEL MK04500 Draeger Medical GmbH | BSZ |
| Dec 10, 2010 | K102618 | VENTSTAR HEATED, INFINITY ID BREATHING CIRCUIT HEATED Draeger Medical AG & Co. KG | BTT |
| Aug 6, 2010 | K092029 | VENTSTAR RESUSCITAIRE, MODEL MP00311, VENTSTAR RESUSCITAIRE CEU, MODEL MP00310 Draeger Medical AG & Co. KG | BYE |
| Apr 23, 2010 | K100941 | INFINITY MCABLE - MAINSTREAM CO2 Draeger Medical AG & Co. KG, DE | CCK |
| Nov 24, 2009 | K092999 | NBP CUFF Draeger Medical AG & Co. KG | DXQ |
| Dec 29, 2008 | K083050 | EVITE XL Draeger Medical AG & Co. KG | CBK |
| Nov 26, 2008 | K082600 | OXYLOG 2000 PLUS SYSTEM (MODEL 5705080), OXYLOG 2000 PLUS BASIC DEVICE (MODEL 5705082) Draeger Medical B.V. | CBK |
| Oct 8, 2008 | K081447 | FOURTH GAS MODULE WITH CO2 FOR PRIMUS US APOLLO Draeger Medical AG & Co. KG, DE | BSZ |
| Sep 22, 2008 | K081743 | CLASSICSTAR NV SE AND NOVASTAR NV SE AND AAV FULL FACE MASKS Draeger Medical AG & Co. KG, DE | CBK |
| Jul 30, 2008 | K072884 | FABIUS MRI Draeger Medical AG & Co. KG | BSZ |
| Apr 7, 2008 | K072885 | CARINA SYSTEM, MODEL 8419350; CARINA BASIC DEVICE, MODEL 5704110 Draeger Medical AG & Co. KG | CBK |
| Jan 31, 2008 | K072002 | FILTER CARESTAR 30; FILTER SAFESTAR 55; FILTER/HME TWINSTAR 55 Draeger Medical AG & Co. KG | CAH |
| Jun 14, 2006 | K060705 | CARINA HOME Draeger Medical B.V. | CBK |
| Nov 26, 2004 | K042607 | PRIMUS US Draeger Medical, Inc. | BSZ |
| Oct 8, 2004 | K042419 | FABIUS GS/FABIUS TIRO ANESTHESIA SYSTEM Draeger Medical, Inc. | BSZ |
| Sep 23, 2004 | K042276 | D-VAPOR Draeger Medical, Inc. | CAD |
| Aug 31, 2004 | K042086 | FABIUS GS ANESTHESIA SYSTEM; FABIUS TIRO ANESTHESIA SYSTEM Draeger Medical, Inc. | BSZ |
| Jul 8, 2004 | K041622 | MODIFICATION TO FABIUS GS ANESTHESIA SYSTEM; FABIUS TIRO ANESTHESIA SYSTEM Draeger Medical, Inc. | BSZ |
| Jun 17, 2004 | K040847 | MODIFICATION TO VAMOS ANESTHETIC GAS MONITOR Draeger Medical, Inc. | CCK |
| Apr 26, 2004 | K033498 | NARKOMED 6400, MODEL NM6400 Draeger Medical, Inc. | BSZ |
| Mar 17, 2004 | K030624 | MODIFICATION TO FABIUS GS ANESTHESIA SYSTEM Draeger Medical, Inc. | BSZ |
| Jul 15, 2003 | K031400 | FABIUS TIRO ANESTHESIA SYSTEM Draeger Medical, Inc. | BSZ |
| Aug 29, 2002 | K022031 | NARKOMED MRI-2 ANESTHESIA SYSTEM, MODEL NM-MRI-2 Draeger Medical, Inc. | BSZ |
| Feb 22, 2002 | K011404 | FABIUS GS ANESTHESIA SYSTEM, MODEL FABIUS GS Draeger Medical, Inc. | BSZ |
| Jan 17, 2002 | K012139 | VAMOS ANESTHETIC GAS MONITOR Draeger Medical, Inc. | CCK |
| Jan 22, 2001 | K003579 | NARKOMED MRI-2, MODEL NM-MRI-2 Draeger Medical, Inc. | BSZ |
| Jun 9, 2000 | K001488 | NARKOMED MRI , NM-MRI Draeger Medical, Inc. | BSZ |
| Mar 23, 2000 | K993826 | NARKOMED 6000 Draeger Medical, Inc. | MLC |
| Jan 11, 1999 | K983635 | JULIAN ANESTHESIA WORKSTATION, MODEL # JULIAN Draeger Medical, Inc. | BSZ |
| Aug 4, 1998 | K980553 | NARKOMED 6000 MODEL NUMBER NM6000 Draeger Medical, Inc. | BSZ |
| Aug 4, 1998 | K980208 | DIVAN ANESTHESIA VENTILATOR Draeger Medical, Inc. | CBK |
| Jul 6, 1998 | K981773 | DRAGER-VAPOR 19.3 Draeger Medical, Inc. | CAD |
| May 29, 1998 | K980886 | BABYTHERM 8000 LDR Draeger Medical, Inc. | FMZ |
| May 7, 1998 | K981472 | DRAGER-VAPOR 19.1 W/PLUG SYSTEM S PLUS Draeger Medical, Inc. | CAD |
| Feb 6, 1998 | K973949 | PERIOPERATIVE DATA MANAGEMENT SYSTEM Draeger Medical, Inc. | BSZ |
| Jan 28, 1998 | K974193 | NARKOMED ULTRASONIC FLOW SENSOR Draeger Medical, Inc. | BSZ |
| Oct 30, 1997 | K973051 | DRAGER-VAPOR 19.1 W/PLUG SYSTEM S PLUS Draeger Medical, Inc. | CAD |
| Oct 30, 1997 | K972848 | NARKOMED MRI ANESTHESIA SYSTEM Draeger Medical, Inc. | BSZ |
| Sep 16, 1997 | K971923 | DRAGER-VAPOR 2000 Draeger Medical, Inc. | CAD |
| Sep 10, 1997 | K971425 | NARKOMED M ANESTHESIA SYSTEM (M) Draeger Medical, Inc. | BSZ |
| Mar 19, 1997 | K963994 | NARKOMED GS ANESTHESIA SYSTEM Draeger Medical, Inc. | BSZ |
| Mar 1, 1996 | K953228 | NARKOMED AV2+ ANESTHESIA VENTILATOR Draeger Medical, Inc. | CBK |
| Feb 3, 1995 | K945463 | PENDANT MOUNT NARKOMED 2C ANESTHESIUA SYSTEM Draeger Medical, Inc. | BSZ |
| Jun 22, 1993 | K930351 | NARKOMED 2C ANESTHESIA SYSTEM Draeger Medical, Inc. | BSZ |
| Nov 3, 1992 | K913995 | VITALERT 3000 MONITORING SYSTEM Draeger Medical, Inc. | CCK |
| Jul 25, 1991 | K912533 | NARKOMED AV-E VENTILATOR Draeger Medical, Inc. | CBK |
| Jul 9, 1990 | K901713 | NARKOMED 4 ANESTHESIA SYSTEM Draeger Medical, Inc. | BSZ |
Newest 50 of 94.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 18, 2024 | Draeger Medical, Inc. Brand Name: Atlan
Product Name: Atlan A300XL
Model/Catalog Number: 8621400
The Atlan is an anesthesia workstation intended for use in anesthetizing adults, pediatrics, and neonates. Open, Classified |
BSZ | K230931 |
| Dec 18, 2024 | Draeger Medical, Inc. Brand Name: Atlan
Product Name: Atlan A300
Model/Catalog Number: 8211300
The Atlan is an anesthesia workstation intended for use in anesthetizing adults, pediatrics, and neonates. Open, Classified |
BSZ | K230931 |
| Nov 13, 2024 | Draeger Medical, Inc. Brand Name: Atlan
Product Name: Atlan A350XL
Model/Catalog Number: 8621600
Software Version: Not Applicable
Component: Not applicable Open, Classified |
BSZ | K230931 |
| Nov 13, 2024 | Draeger Medical, Inc. Brand Name: Atlan
Product Name: Atlan A350
Model/Catalog Number: 8211500
Software Version: Not applicable
Component: Not applicable Open, Classified |
BSZ | K230931 |
| Apr 18, 2024 | Draeger Medical, Inc. Drger Perseus A500 Anesthesia Workstation Open, Classified |
BSZ | K133886 |
| Aug 18, 2023 | Draeger Medical, Inc. Carina Sub-Acute Care Ventilator Open, Classified |
CBK | K072885 |
| Jul 8, 2023 | Draeger Medical, Inc. Oxylog 3000 Plus emergency and transport ventilator Open, Classified |
CBK | K103625 |
| May 17, 2023 | Draeger Medical, Inc. Anesthesia Circuit Kit Coax HEPA, MP17102 Terminated |
CAI | None listed |
| May 17, 2023 | Draeger Medical, Inc. Set2Go Ventilation 12 (A), MP07968 Terminated |
CAI | None listed |
| May 17, 2023 | Draeger Medical, Inc. Anesthesia Set Coax 180, MP03384 Terminated |
CAI | None listed |
| May 17, 2023 | Draeger Medical, Inc. Ventstar Coax 230, MP03376 Terminated |
BZO | None listed |
| May 17, 2023 | Draeger Medical, Inc. ID Coax 180, MP03375 Terminated |
BZO | None listed |
| May 17, 2023 | Draeger Medical, Inc. Ventstar Coax 180, MP03374 Terminated |
BZO | None listed |
| May 17, 2023 | Draeger Medical, Inc. Ventstar Coax, MP03373 Terminated |
BZO | None listed |
| May 17, 2023 | Draeger Medical, Inc. Anesthesia Circuit Kit Coax 3, MP02732 Terminated |
CAI | None listed |
| May 17, 2023 | Draeger Medical, Inc. Anesthesia Circuit Kit Coax 1, MP02730 Terminated |
CAI | None listed |
| May 17, 2023 | Draeger Medical, Inc. VentStar Coax (P) 150, MP00379 Terminated |
BZO | None listed |
| May 17, 2023 | Draeger Medical, Inc. VentStar Bag Set (N) 110, MP00383 Terminated |
BTC | None listed |
| May 17, 2023 | Draeger Medical, Inc. VentStar Watertrap (N) 180, MP00363 Terminated |
CAI | None listed |
| May 17, 2023 | Draeger Medical, Inc. VentStar Basic (N) 180, MP00353 Terminated |
CAI | None listed |
| May 17, 2023 | Draeger Medical, Inc. VentStar Anesthesia (N) 180, MP00333 Terminated |
CAI | None listed |
| May 17, 2023 | Draeger Medical, Inc. ID Circuit Basic (P) 180, MP01340 Terminated |
BZO | None listed |
| May 17, 2023 | Draeger Medical, Inc. VentStar breathing bag Set (P) 110, MP00384 Terminated |
BTC | None listed |
| May 17, 2023 | Draeger Medical, Inc. VentStar Anesthesia WT (P)180, MP00374 Terminated |
CAI | None listed |
| May 17, 2023 | Draeger Medical, Inc. VentStar Watertrap (P) 180 w/oLL, MP00362 Terminated |
CAI | None listed |
| May 17, 2023 | Draeger Medical, Inc. VentStar Watertrap (P) 180, MP00361 Terminated |
CAI | None listed |
| May 17, 2023 | Draeger Medical, Inc. VentStar Basic (P)250, MP00352 Terminated |
CAI | None listed |
| May 17, 2023 | Draeger Medical, Inc. VentStar Basic (P)180, MP00351 Terminated |
CAI | None listed |
| May 17, 2023 | Draeger Medical, Inc. Seattle PAP Plus, MP02260 Terminated |
BZD | K131502 |
| Feb 24, 2023 | Draeger Medical, Inc. NovaStar TS, Standard elbow, Reusable, Material Numbers MP01579 (Size S), MP01580 (Size M), and MP01581 (Size L) Open, Classified |
CBK | K081743 |
| Feb 24, 2023 | Draeger Medical, Inc. NovaStar TS, Anti-Asphyxia Valve, Reusable, Material Numbers MP01576 (Size S), MP01577 (Size M), and MP01578 (Size L) Open, Classified |
CBK | K081743 |
| May 16, 2022 | Draeger Medical, Inc. Drager SafeStar 55, Catalog No. MP01790 Open, Classified |
CAH | K072002 |
| Feb 14, 2022 | Draeger Medical, Inc. Babylog VN500 Ventilator with Software 2.51.01 and Lower- intended for the ventilation neonatal patients from 0.4 kg (0.88 lbs) up to 10 kg (22 lbs) and pediatric patients from 5 kg (11 lbs) up to 20 Terminated |
CBK | K093632 |
| Feb 14, 2022 | Draeger Medical, Inc. Evita V500 Ventilator with Software 2.51.01 and Lower - intended for the ventilation of adult, pediatric and neonatal patients
Catalog Number: 8416400 Terminated |
CBK | K093633 |
| Dec 16, 2021 | Draeger Medical, Inc. Draeger Fabius MRI Anesthesia Machine, Catalog Number 8607300 Terminated |
BSZ | K072884 |
| Sep 10, 2021 | Draeger Medical, Inc. Babylog VN500 Ventilator with Installed CO2 Measurement Option-intended for the ventilation of neonatal patients from 0.4 kg (0.88 lbs) up to 10 kg (22 lbs) and
pediatric patients from 5 kg (11 lbs) u Open, Classified |
CBK | K093632 |
| Sep 10, 2021 | Draeger Medical, Inc. Evita V500 Ventilator with Installed CO2 Measurement Option-Intended for the ventilation of adult,pediatric and neonatal patients.
Catalog Number: 8416400 Open, Classified |
CBK | K093633 |
| Apr 16, 2021 | Draeger Medical, Inc. Critical Care Ventilator, Catalog Number(s): 8422400: Babylog VN800 - Product Usage: used for treating patients who require temporary or longer term respiratory support for different medical reasons. Terminated |
CBK | None listed |
| Apr 16, 2021 | Draeger Medical, Inc. Critical Care Ventilator, Catalog Number(s): 8422200: Babylog VN600 - Product Usage: used for treating patients who require temporary or longer term respiratory support for different medical reasons. Terminated |
CBK | None listed |
| Apr 16, 2021 | Draeger Medical, Inc. Critical Care Ventilator, Catalog Number(s): 8422500: Evita V800 - Product Usage: used for treating patients who require temporary or longer term respiratory support for different medical reasons. Terminated |
CBK | None listed |
| Apr 16, 2021 | Draeger Medical, Inc. Critical Care Ventilator, Catalog Number(s): 8422300: Evita V600 - Product Usage: used for treating patients who require temporary or longer term respiratory support for different medical reasons. Terminated |
CBK | None listed |
| Jan 29, 2021 | Draeger Medical, Inc. ID Circuit Basic (N) 180-Drager Breathing Circuits/Anesthesia Sets Order Number: MP01327 - Product Usage: Breathing circuit for conduction of respiratory gases between anesthesia machine or ventilato Terminated |
OFP | None listed |
| Jan 29, 2021 | Draeger Medical, Inc. VentStar Watertrap (N) 180-Drager Breathing Circuits/Anesthesia Sets Order Number: MP00363 - Product Usage: Breathing circuit for conduction of respiratory gases between anesthesia machine or ventilat Terminated |
OFP | None listed |
| Jan 29, 2021 | Draeger Medical, Inc. VentStar Basic (N) 180- Drager Breathing Circuits/Anesthesia Sets Order Number: MP00353 - Product Usage: Breathing circuit for conduction of respiratory gases between anesthesia machine or ventilator Terminated |
OFP | None listed |
| Jan 29, 2021 | Draeger Medical, Inc. VentStar Anesthesia (N) 180 - Drager Breathing Circuits/Anesthesia Sets Order Number: MP00333 - Product Usage: Breathing circuit for conduction of respiratory gases between anesthesia machine or venti Terminated |
OFP | None listed |
| Jan 24, 2019 | Draeger Medical, Inc. ID Circuit Basic 180, Catalog Number MP01350
Breathing Circuits/Anesthesia Sets without a Water trap: Breathing circuit for conduction of respiratory gases between anesthesia machine or ventilator a Terminated |
OFP | None listed |
| Jan 24, 2019 | Draeger Medical, Inc. ID Circuit Basic 250, Catalog Number MP01348
Breathing Circuits/Anesthesia Sets without a Water trap: Breathing circuit for conduction of respiratory gases between anesthesia machine or ventilator a Terminated |
OFP | None listed |
| Jan 24, 2019 | Draeger Medical, Inc. ID Circuit Watertrap (P) 180, Catalog Number MP01341
Breathing Circuits/Anesthesia Sets without a Water trap: Breathing circuit for conduction of respiratory gases between anesthesia machine or ven Terminated |
OFP | None listed |
| Jan 24, 2019 | Draeger Medical, Inc. VentStar Anesthesia WT(P) 180, Catalog Number MP00374
Breathing Circuits/Anesthesia Sets without a Water trap: Breathing circuit for conduction of respiratory gases between anesthesia machine or ven Terminated |
OFP | None listed |
| Jan 24, 2019 | Draeger Medical, Inc. VentStar Watertrap (P) 180, Catalog Number MP00361
Breathing Circuits/Anesthesia Sets without a Water trap: Breathing circuit for conduction of respiratory gases between anesthesia machine or ventil Terminated |
OFP | None listed |
Newest 50 of 103.