Data / Medical devices / United States / Draeger Medical Systems, Inc.
Draeger Medical Systems, Inc.: FDA-registered device maker in Andover, MA, United States, 27 510(k) clearances
Draeger Medical Systems, Inc. is registered with the FDA (registration 3005783425) in Andover, MA, United States. It lists 41 device types. The FDA files 27 510(k) clearances under its listings, the newest dated August 20, 2026. 13 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3005783425
- Address
- 6 Tech Drive, Andover, MA, United States, 01810
- Owner or operator
- Draeger Medical Systems, Inc. (9070398)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- November 7, 2006
- Registered through
- 2026
- Brand names listed
- CNAP Accessories, ECG Electrodes, Disposable, EEG Infinity Pod, FI02 Sensor Cable, Gateway, IACS, INFINITY DELTA, DELTA XL & KAPPA MONITORS WITH INFINITY MCABLE MAINSTREAM CO2, INFINITY EXPLORER and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 20, 2026 | K260579 | Infinity® Acute Care System (IACS) VG8.1 | MHX | Substantially Equivalent | Draeger Medical Systems, Inc. | accessdata.fda.gov |
| August 1, 2024 | K240312 | Infinity CentralStation Wide | MHX | Substantially Equivalent | Draeger Medical Systems, Inc. | accessdata.fda.gov |
| July 12, 2024 | K233834 | Infinity Gateway Suite | MSX | Substantially Equivalent | Draeger Medical Systems, Inc. | accessdata.fda.gov |
| October 17, 2023 | K231477 | Infinity CentralStation Wide, Infinity M300, Infinity M300+ | MHX | Substantially Equivalent | Draeger Medical Systems, Inc. | accessdata.fda.gov |
| June 7, 2022 | K203579 | Infinity Gateway Suite | MSX | Substantially Equivalent | Draeger Medical Systems, Inc. | accessdata.fda.gov |
| February 1, 2022 | K203088 | Infinity Acute Care System (IACS) Monitoring System | MHX | Substantially Equivalent | Draeger Medical Systems, Inc. | accessdata.fda.gov |
| September 23, 2015 | K152407 | Infinity Delta, Infinity Delta XL, Infinity Kappa | MHX | Substantially Equivalent | Draeger Medical Sytems, Inc. | accessdata.fda.gov |
| December 12, 2014 | K141756 | INFINITY EXPLORER SOFTWARE, C700 FOR IT PATIENT VICINITY WORKSTATION | MSX | Substantially Equivalent | Draeger Medical Systems, Inc. | accessdata.fda.gov |
| April 11, 2013 | K130711 | INFINITY CENTRALSTATION WITH INFINITY M300 | MHX | Substantially Equivalent | Draeger Medical Systems, Inc. | accessdata.fda.gov |
| March 22, 2012 | K113798 | INFINITY ACUTE CARE SYSTEM, INFINITY MCABLE- MASIMO RAINBOW SET | MHX | Substantially Equivalent | Draeger Medical Systems, Inc. | accessdata.fda.gov |
| February 18, 2011 | K102968 | INFINITY CNAP SMARTPOD | DXN | Substantially Equivalent | Draeger Medical Systems, Inc. | accessdata.fda.gov |
| November 26, 2008 | K082888 | INFINITY NELLCOR OXIMAX SMARTPOD, MODEL MS23997 | DQA | Substantially Equivalent | Draeger Medical Systems, Inc. | accessdata.fda.gov |
| January 3, 2008 | K073113 | INFINITY PICCO POD, MODEL MS16734 | DXG | Substantially Equivalent | Draeger Medical Systems, Inc. | accessdata.fda.gov |
| June 4, 2007 | K070566 | INFINITY DELTA/DELTA XL/ KAPPA/ GAMMA X XL/ VISTA XL/ SC7000/SC8000/ SC9000XL | MHX | Substantially Equivalent | Draeger Medical Systems, Inc. | accessdata.fda.gov |
| February 16, 2007 | K061379 | INFINITY TELESMART TELEMETRY SYSTEM | MHX | Substantially Equivalent | Draeger Medical Systems, Inc. | accessdata.fda.gov |
| July 7, 2006 | K061329 | INFINITY MASIMO SET SP02 POD | DQA | Substantially Equivalent | Draeger Medical Systems, Inc. | accessdata.fda.gov |
| April 12, 2006 | K060223 | INFINITY MULTIVIEW INFINITY TELEMETRY SYSTEM | MHX | Substantially Equivalent | Draeger Medical Systems, Inc. | accessdata.fda.gov |
| February 22, 2006 | K053484 | INFINITY GAMMA / GAMMAXL, INFINITY VISTA | MHX | Substantially Equivalent | Draeger Medical Systems, Inc. | accessdata.fda.gov |
| April 29, 2005 | K050974 | DRAEGER MEDICAL INFORMATION BUS (MIB, MIB II, MIB DUO) PROTOCOL CONVERTERS | DRQ | Substantially Equivalent | Draeger Medical Systems, Inc. | accessdata.fda.gov |
| February 18, 2005 | K042904 | INFINITY KAPPA XLT | MHX | Substantially Equivalent | Draeger Medical Systems, Inc. | accessdata.fda.gov |
| January 21, 2005 | K043549 | INFINITY GATEWAY SUITE, VF4 | MHX | Substantially Equivalent | Draeger Medical Systems, Inc. | accessdata.fda.gov |
| September 1, 2004 | K042003 | INFINITY TRIDENT NMT POD | KOI | Substantially Equivalent | Draeger Medical Systems, Inc. | accessdata.fda.gov |
| March 7, 2001 | K003550 | INFINITY ETCO2 + RESPIRATORY MECHANICS POD | CCK | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| November 3, 1999 | K991884 | SIEMENS FIO2 SENSOR | CCL | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| June 24, 1999 | K991012 | SIEMENS INFINITY EEG POD | OLT | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| August 12, 1998 | K980287 | SIEMENS SC9000/SC9015 TCP02/C02 MODULE | KLK | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| February 5, 1996 | K954632 | SIEMENS SC 9000 ETCO2 MODULE | CCK | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| January 14, 2025 | 96057 | Class II | Ongoing | 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 environment. Centrali | Edifier speakers (shipped in or after April 2023) may not annunciate when configured in analog mode which can lead to delayed treatment to the patient. | accessdata.fda.gov |
| May 13, 2024 | 94644 | Class II | Ongoing | Infinity Acute Care System (IACS) Monitoring System, Infinity M500 with Power, Model No. MS20407. Rev 20, 21, and 23 | Device is not in full compliance to Type CF requirements of IEC 60601-1 and IEC 60601-2-34 standards. Therefore, there is a potential risk of electric shock. Health consequences may include electrical shock, burns, and cardiac arrhythmia. | accessdata.fda.gov |
| April 5, 2023 | 91938 | Class II | Ongoing | 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 | The software on the Infinity CentralStation drops peaks on narrow waveforms causing the Infinity M300 to fail to meet Frequency and Impulse Response requirements. In this condition, ECG waveforms with unusually narrow and/or high frequency QRS may be displayed or printed with QRS amplitudes intermittently lower than actual. | accessdata.fda.gov |
| March 4, 2022 | 89877 | Class II | Ongoing | Drager Infinity CentralStation Software versions VG2.1.2 and VG2.1.2 SU12. For patient monitoring with Infinity M300 wireless telemetry devices. | Software issue resulting in temporary loss of central monitoring functionality. | accessdata.fda.gov |
| December 23, 2020 | 87176 | Class II | Ongoing | Infinity Acute Care System (IACS) Monitoring Solution: The IACS is intended for multi-parameter, physiologic patient monitoring of adult, pediatric and neonatal patients in environments where patient care is provided by | The Infinity M540 patient monitor may randomly reboot due to an error to correctly transmit and read the header data of files in the memory of the device. Under this situation, the device will try to reboot to mitigate the error. The device will be available again for use within 30 seconds. If this error continues and the M540 reboots three times in a time s | accessdata.fda.gov |
| October 9, 2019 | 84028 | Class II | Ongoing | Infinity M300 telemetry monitoring device Software versions VG2.3.1 and lower, Model Numbers MS25755, MS26076, MS26031, MS18623, MS22862, MS25301 | The devices have potential cybersecurity vulnerabilities, which can include Distributed Denial of Service (DDoS), Spoofing, and Tampering. | accessdata.fda.gov |
| September 13, 2019 | 83889 | Class II | Ongoing | The Infinity Acute Care System (IACS) Monitoring Solution with the Standalone Infinity M540 patient monitor. Model nos. MS25510, MS25520, MS26372. | Cybersecurity vulnerabilities may cause device to reboot, lose alarm functionality, and/or lose communication with cockpit and/or the Infinity Network. | accessdata.fda.gov |
| February 8, 2019 | 82014 | Class II | Ongoing | Infinity Delta Family patient monitors The Infinity Delta Series (Delta/Delta XL/Kappa) monitors are intended to be used on adult, pediatric, and neonatal populations, with the exception of the parameter Cardiac Output, | The firm is recalling their Delta family of patient monitors software due to cybersecurity vulnerabilities, which may cause the device to reboot, lose functionality, and/or lose communication. | accessdata.fda.gov |
| March 28, 2018 | 79871 | Class II | Terminated | Infinity Acute Care System (lACS) Monitoring Solution; Catalog Numbers:MS20401, MS20724, MS22956, MS25510, MS25520, MS25643, MS26196, MS26372, MS31818; UDI Information: 4049098054454, 4049098054447, 4049098054409, 404909 | Software anomaly resulting in the loss of patient settings and stored patient data. | accessdata.fda.gov |
| February 21, 2018 | 79648 | Class II | Terminated | Infinity Acute Care System (IACS) Monitoring Solution, Catalog Numbers: MS18841, MS20401, MS20407, MS20724, MS22956, MS25510, MS25520, MS25643, MS26196, MS26372, MS31818; UDI Information: 4049098054454, 4049098054447, 40 | The invasive pressure visual and audible alarms may not activate. | accessdata.fda.gov |
| October 4, 2017 | 79209 | Class II | Terminated | INFINITY DUAL HEMO MCable Pod | Dual Hemo MCable Pods with Revision Index (RI) 15 and 16, which are used with the Drger Infinity Acute Care System, may permit liquid ingress inconsistent with their IPX4 rating, which could potentially result in an incorrect measured value of invasive blood pressure. | accessdata.fda.gov |
| June 6, 2017 | 77505 | Class II | Terminated | Draeger Medical Systems Infinity Acute Care System (M540) Catalog Numbers: MK31501/MK31701/MK31722 | Cockpits with revision index 06 or higher that contain 4GB RAM modules may not annunciate audio or visual alarms on the Cockpit and Central Station. | accessdata.fda.gov |
| March 28, 2017 | 76862 | Class II | Terminated | Delta, Catalog Number: MS18597 in combination with Scio, Scio Four, Scio Four Oxi plus, Scio Four Oxi, Scio Four plus. Product Usage: The devices are intended to be used in the environment where patient care is provided | It was reported that a set low O2 alarm does not go off although the measured O2 level is below the alarm limit. | accessdata.fda.gov |
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Updated August 20, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.