Company · US
Draeger Medical Systems, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2003 to 2026. Name variants (Inc, Corp, punctuation) are merged.
49510(k) clearances (1 in 12 months)
21recalls (0 in 12 months)
21recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | 34 |
| FMT | Warmer, Infant Radiant | 6 |
| MSX | System, Network And Communication, Physiological Monitors | 5 |
| CBK | Ventilator, Continuous, Facility Use | 3 |
| DQA | Oximeter | 3 |
| LBI | Unit, Neonatal Phototherapy | 3 |
| MQM | Bilirubin (Total And Unbound) In The Neonate Test System | 3 |
| BSZ | Gas-Machine, Anesthesia | 2 |
| DRQ | Amplifier And Signal Conditioner, Transducer Signal | 2 |
| FPL | Incubator, Neonatal Transport | 2 |
| BTL | Ventilator, Emergency, Powered (Resuscitator) | 1 |
| DSI | Detector And Alarm, Arrhythmia | 1 |
| DXG | Computer, Diagnostic, Pre-Programmed, Single-Function | 1 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 1 |
| FMZ | Incubator, Neonatal | 1 |
| KOI | Stimulator, Nerve, Peripheral, Electric | 1 |
| NHP | Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration) | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 20, 2026 | K260579 | Infinity® Acute Care System (IACS) VG8.1 Draeger Medical Systems, Inc. | MHX |
| Jan 17, 2025 | K243606 | Babyroo TN300 Draeger Medical Systems, Inc. | FMT |
| Aug 1, 2024 | K240312 | Infinity CentralStation Wide Draeger Medical Systems, Inc. | MHX |
| Jul 12, 2024 | K233834 | Infinity Gateway Suite Draeger Medical Systems, Inc. | MSX |
| Oct 17, 2023 | K231477 | Infinity CentralStation Wide, Infinity M300, Infinity M300+ Draeger Medical Systems, Inc. | MHX |
| May 30, 2023 | K230278 | Babyroo TN300 Draeger Medical Systems, Inc. | FMT |
| Jun 7, 2022 | K203579 | Infinity Gateway Suite Draeger Medical Systems, Inc. | MSX |
| Feb 1, 2022 | K203088 | Infinity Acute Care System (IACS) Monitoring System Draeger Medical Systems, Inc. | MHX |
| Dec 9, 2021 | K201764 | Infinity Acute Care System (IACS) Monitoring Solution Draeger Medical Systems, Inc. | MHX |
| Aug 28, 2020 | K200859 | Infinity M300 Draeger Medical Systems, Inc. | MHX |
| Nov 21, 2018 | K182977 | Isolette 8000 Plus Draeger Medical Systems, Inc. | FMZ |
| May 1, 2018 | K172656 | BiliLux Draeger Medical Systems, Inc. | LBI |
| Sep 2, 2015 | K151860 | Infinity CentralStation Wide Draeger Medical Systems, Inc. | MHX |
| Dec 12, 2014 | K141756 | INFINITY EXPLORER SOFTWARE, C700 FOR IT PATIENT VICINITY WORKSTATION Draeger Medical Systems, Inc. | MSX |
| Nov 13, 2014 | K133175 | DRAEGER JAUNDICE METER JM-105 Draeger Medical Systems, Inc. | MQM |
| Sep 10, 2014 | K141565 | GLOBE-TROTTER GT5400 Draeger Medical Systems, Inc. | FPL |
| Apr 11, 2013 | K130711 | INFINITY CENTRALSTATION WITH INFINITY M300 Draeger Medical Systems, Inc. | MHX |
| Nov 2, 2012 | K120642 | RESUSCITAIRE WITH AUTOBREATH Draeger Medical Systems, Inc. | FMT |
| Mar 22, 2012 | K113798 | INFINITY ACUTE CARE SYSTEM, INFINITY MCABLE- MASIMO RAINBOW SET Draeger Medical Systems, Inc. | MHX |
| Feb 17, 2012 | K113206 | NANOBLUTM 500 Draeger Medical Systems, Inc. | LBI |
| Oct 6, 2011 | K103625 | OXYLOG 3000 PLUS WORKSTATION, OXYLOG 3000 PLUS BASIC DEVICE Draeger Medical Systems, Inc. | CBK |
| Feb 18, 2011 | K102968 | INFINITY CNAP SMARTPOD Draeger Medical Systems, Inc. | DXN |
| Mar 8, 2010 | K093788 | INFINITY ACUTE CARE SYSTEM (IACS) MONITORING SOLUTION Draeger Medical Systems, Inc. | MHX |
| Nov 26, 2008 | K082888 | INFINITY NELLCOR OXIMAX SMARTPOD, MODEL MS23997 Draeger Medical Systems, Inc. | DQA |
| Jan 3, 2008 | K073113 | INFINITY PICCO POD, MODEL MS16734 Draeger Medical Systems, Inc. | DXG |
| Jun 4, 2007 | K070566 | INFINITY DELTA/DELTA XL/ KAPPA/ GAMMA X XL/ VISTA XL/ SC7000/SC8000/ SC9000XL Draeger Medical Systems, Inc. | MHX |
| Feb 16, 2007 | K061379 | INFINITY TELESMART TELEMETRY SYSTEM Draeger Medical Systems, Inc. | MHX |
| Jul 7, 2006 | K061329 | INFINITY MASIMO SET SP02 POD Draeger Medical Systems, Inc. | DQA |
| Apr 12, 2006 | K060223 | INFINITY MULTIVIEW INFINITY TELEMETRY SYSTEM Draeger Medical Systems, Inc. | MHX |
| Apr 12, 2006 | K060039 | INFINITY DELTA AND KAPPA SERIES MONITORS WITH VF6 MODIFICATIONS Draeger Medical Systems, Inc. | MHX |
| Apr 4, 2006 | K060254 | MODIFICATION TO INFINITY EXPLORER Draeger Medical Systems, Inc. | MSX |
| Feb 22, 2006 | K053484 | INFINITY GAMMA / GAMMAXL, INFINITY VISTA Draeger Medical Systems, Inc. | MHX |
| Nov 16, 2005 | K051658 | INFINITY ALPHA Draeger Medical Systems, Inc. | MHX |
| Jul 20, 2005 | K051628 | INFINITY MONITORS WITH SCIO MODIFICATIONS Draeger Medical Systems, Inc. | MHX |
| Apr 29, 2005 | K050974 | DRAEGER MEDICAL INFORMATION BUS (MIB, MIB II, MIB DUO) PROTOCOL CONVERTERS Draeger Medical Systems, Inc. | DRQ |
| Feb 18, 2005 | K043439 | INFINITY MODULAR MONITORS WITH VF5 MODIFICATIONS (DELTA/KAPPA/DELTA XL/VISTA XL/GAMMA X XL AND SC 7000/8000/9000XL Draeger Medical Systems, Inc. | MHX |
| Feb 18, 2005 | K042904 | INFINITY KAPPA XLT Draeger Medical Systems, Inc. | MHX |
| Jan 21, 2005 | K043549 | INFINITY GATEWAY SUITE, VF4 Draeger Medical Systems, Inc. | MHX |
| Oct 6, 2004 | K042656 | INFINITY GAMMA/GAMMAXL AND VISTA WITH VF5 Draeger Medical Systems, Inc. | MHX |
| Sep 1, 2004 | K042003 | INFINITY TRIDENT NMT POD Draeger Medical Systems, Inc. | KOI |
| May 14, 2004 | K033957 | INFINITY MODULAR MONITORS VF4 MODIFICATIONS WITH SCIO, MODELS DELTA, DELTA XL, KAPPA, SC 8000, SC 7000, SC 9000XL Draeger Medical Systems, Inc. | MHX |
| May 12, 2004 | K041087 | INFINITY GAMMA Draeger Medical Systems, Inc. | MHX |
| May 12, 2004 | K040945 | MODIFICATION TO INFINITY EXPLORER Draeger Medical Systems, Inc. | MSX |
| Apr 14, 2004 | K040188 | INFINITY GAMMAXL AND SC 6802XL WITH THE SCIO GAS MODULE Draeger Medical Systems, Inc. | NHP |
| Mar 22, 2004 | K033694 | INFINITY MODULAR MONITORS VF4 MODIFICATIONS Draeger Medical Systems, Inc. | MHX |
| Mar 9, 2004 | K033807 | INFINITYEDICAL INFORMATION BUS (MIB/MIB II AND MIB DUO) PROTOCOL CONVERTER Draeger Medical Systems, Inc. | DRQ |
| Dec 11, 2003 | K033600 | INFINITY GAMMAXL Draeger Medical Systems, Inc. | MHX |
| Nov 25, 2003 | K032537 | DRAEGER MICRO2+ AND MASIMO MINISAT Draeger Medical Systems, Inc. | DQA |
| Oct 31, 2003 | K033305 | INFINITY MULTIVIEW INFINITY TELEMETRY SYSTEM Draeger Medical Systems, Inc. | DSI |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 30, 2025 | Draeger Medical Systems, Inc. Infinity Central Station. Model Number: MS26800
The Infinity CentralStation (ICS) is intended for centralized monitoring of adult, pediatric and neonatal patient data within the hospital or clinical Open, Classified |
MHX | K151860 |
| Jun 25, 2024 | Draeger Medical Systems, Inc. Infinity Acute Care System (IACS) Monitoring System, Infinity M500 with Power, Model No. MS20407. Rev 20, 21, and 23 Open, Classified |
MHX | K203088 |
| Jun 22, 2023 | Draeger Medical Systems, Inc. Draeger Softbed Resuscitaire and/or Birthing Room Warmer with Scale [Model(s): RW82VHA-1, RW82VHA-1C, RW82VHA-1D, RW82-1, RW82-1C, RW82-1D, WBR82-1 and WBR82-1C] Open, Classified |
FMT | K120642 |
| Apr 27, 2023 | Draeger Medical Systems, Inc. Draeger Infinity M300 and M300+, for use with the ICS to monitor ECG and pulse oximetry on ambulatory and non-ambulatory adult and pediatric patients using wireless communication over the Infinity pat Open, Classified |
MHX | K200859 |
| Apr 27, 2023 | Draeger Medical Systems, Inc. Draeger Infinity CentralStation (ICS), centralized monitoring of adult, pediatric and neonatal patient data within the hospital or clinical environment, Software versions VG2.1.3 and lower Open, Classified |
MHX | K151860 |
| May 20, 2022 | Draeger Medical Systems, Inc. Draeger Globe-Trotter and Globe-Trotter IC, Model numbers MS20508 and MS20509. neonatal transport system Open, Classified |
FPL | K141565 |
| Jun 7, 2018 | Draeger Medical Systems, Inc. Draeger Jaundice Meter JM-105
The device is intended for use in hospitals, clinics or doctor s offices under a physician s supervision / direction to assist clinicians in monitoring of newborn infant Terminated |
MQM | K133175 |
| Jun 7, 2018 | Draeger Medical Systems, Inc. Draeger Jaundice Meter JM-103
The device is intended for use in hospitals, clinics or doctor s offices under a physician s supervision / direction to assist clinicians in monitoring of newborn infan Terminated |
MQM | K042522 |
| Apr 10, 2014 | Draeger Medical Systems, Inc. Draeger Oxylog 3000 plus ventilators, emergency and transport ventilator. Part number: 5704833 Terminated |
BTL | K103625 |
| Mar 28, 2014 | Draeger Medical Systems, Inc. Draeger PS500 Power Supply Unit of the Infinity ACS Workstation Critical Care (Evita Infinity V500), Evita V500 and /or Babylog VN500 Ventilators, used for ventilation during short term transport of Terminated |
CBK | K093632 K093633 |
| Jan 10, 2014 | Draeger Medical Systems, Inc. Draeger Infinity Acute Care System Monitoring Solution Terminated |
MHX | K113798 |
| Jul 6, 2012 | Draeger Medical Systems, Inc. Drager PT 4000 Phototherapy System Terminated |
LBI | K954611 |
| Aug 22, 2011 | Draeger Medical Systems, Inc. Infinity Gamma X XL Portable Patient Monitor.
Draeger Medical Systems, Inc.
Portable monitor used to monitor vital signs of neonatal, pediatric, and adult patients for bedside and transport applica Terminated |
MHX | K070566 |
| Aug 22, 2011 | Draeger Medical Systems, Inc. Infinity Delta Portable Patient Monitor.
Draeger Medical Systems, Inc.
Portable monitor used to monitor vital signs of neonatal, pediatric, and adult patients for bedside and transport applications Terminated |
MHX | K070566 |
| Oct 7, 2010 | Draeger Medical Systems, Inc. Oxylog 3000, Emergency and Transport Ventilator; Catalog #2M86300; Drager Medical Inc., 3135 Quarry Road, Telford, PA 18969. Terminated |
CBK | K062267 |
| Sep 23, 2010 | Draeger Medical Systems, Inc. Fabius Tiro Anesthesia Machine, OR/Anesthesia, Draeger Medical, Inc., 3135 Quarry Road, Telford, PA 18969
Compact anesthesia system that offers the full spectrum of anesthesia ventilation to military Terminated |
BSZ | K042419 |
| Sep 23, 2010 | Draeger Medical Systems, Inc. Fabius GS Anesthesia Machine, OR/Anesthesia, Draeger Medical, Inc., 3135 Quarry Road, Telford, PA 18969
inhalation anesthesia machine for use in operating, induction and recovery rooms Terminated |
BSZ | K042419 |
| Aug 26, 2010 | Draeger Medical Systems, Inc. Infinity Delta/Gamma X XL Patient Monitor. Portable monitor used to monitor vital signs of neonatal, pediatric, and adult patients for bedside and transport applications. Terminated |
MHX | K070566 |
| Aug 26, 2010 | Draeger Medical Systems, Inc. Infinity Delta/Gamma X XL Patient Monitor. Portable monitor used to monitor vital signs of neonatal, pediatric, and adult patients for bedside and transport applications. Terminated |
MHX | K070566 |
| Aug 26, 2009 | Draeger Medical Systems, Inc. Heater Elements for Resuscitaire Infant Radiant Warmers model numbers RW82, RW82 VHA, WBR82, and WMRW82, 120 volt configuration only. Terminated |
FMT | K003335 |
| Aug 25, 2009 | Draeger Medical Systems, Inc. Stabilet Infant Warming System, model numbers 200, 300, 1250, 1500, 200/3000, 2000, 2200/3200, 3000, and 3200. Terminated |
FMT | K042607 K850069 +1 |