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Draeger Medical Systems, Inc.: FDA-registered device maker in Telford, PA, United States, 10 510(k) clearances

Name: Draeger Medical Systems, Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Draeger Medical Systems, Inc. is registered with the FDA (registration 2510954) in Telford, PA, United States. It lists 5 device types. The FDA files 10 510(k) clearances under its listings, the newest dated January 17, 2025. 13 recall events name it as the recalling firm (3 Class I). Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 2510954
Address: 3135 Quarry RD., Telford, PA, United States, 18969
Owner or operator: Draeger Medical Systems, Inc. (9070398)
Roles: Manufacturer, Repackager or relabeler, Specification developer
First device listed: December 14, 2007
Registered through: 2026
Brand names listed: Babyroo TN300, BiliLux Phototherapy Light, C2HS Isolette Infant Incubator, Isolette 8000 plus, Isolette 8000 plus Infant Incubator, Jaundice Meter-JM105, RW Resuscitaire, TI500 Globetrotter Transport System and more

Devices it lists

Device	Product code	Class	Role	Source
Bilirubin (Total And Unbound) In The Neonate Test System	MQM	1	Repackager or relabeler, Specification developer	accessdata.fda.gov
Incubator, Neonatal	FMZ	2	Manufacturer	accessdata.fda.gov
Incubator, Neonatal Transport	FPL	2	Manufacturer	accessdata.fda.gov
Unit, Neonatal Phototherapy	LBI	2	Repackager or relabeler, Specification developer	accessdata.fda.gov
Warmer, Infant Radiant	FMT	2	Manufacturer	accessdata.fda.gov

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
January 17, 2025	K243606	Babyroo TN300	FMT	Substantially Equivalent	Draeger Medical Systems, Inc.	accessdata.fda.gov
May 30, 2023	K230278	Babyroo TN300	FMT	Substantially Equivalent	Draeger Medical Systems, Inc.	accessdata.fda.gov
November 21, 2018	K182977	Isolette 8000 Plus	FMZ	Substantially Equivalent	Draeger Medical Systems, Inc.	accessdata.fda.gov
May 1, 2018	K172656	BiliLux	LBI	Substantially Equivalent	Draeger Medical Systems, Inc.	accessdata.fda.gov
April 19, 2018	K172154	Isolette 8000 plus	FMZ	Substantially Equivalent	Draeger Medical Sytems, Inc.	accessdata.fda.gov
November 13, 2014	K133175	DRAEGER JAUNDICE METER JM-105	MQM	Substantially Equivalent	Draeger Medical Systems, Inc.	accessdata.fda.gov
November 2, 2012	K120642	RESUSCITAIRE WITH AUTOBREATH	FMT	Substantially Equivalent	Draeger Medical Systems, Inc.	accessdata.fda.gov
July 13, 2000	K001242	ISOLETTE INFANT INCUBATOR, MODEL C2HS	FMZ	Substantially Equivalent	Hill-Rom Air-Shields	accessdata.fda.gov
April 27, 2000	K001019	TI500 GLOBE-TROTTER TRANSPORT SYSTEM	FPL	Substantially Equivalent	Hill-Rom Air-Shields	accessdata.fda.gov
June 10, 1994	K941106	MODEL TI500 ISOLETTE INFANT INCUBATOR	FPL	Substantially Equivalent	Air-Shields, 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
May 16, 2023	92353	Class II	Ongoing	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]	The Resuscitaire Infant Radiant Warmer with the optional scale could display inaccurate weight values.	accessdata.fda.gov
May 20, 2022	90423	Class II	Ongoing	Draeger Globe-Trotter and Globe-Trotter IC, Model numbers MS20508 and MS20509. neonatal transport system	The firm has initiated this recall to replace component on devices distributed containing a component within the oxygen supply system that is not rated to the working pressure of the system.	accessdata.fda.gov
May 15, 2018	79963	Class I	Terminated	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 infants. The device is not	Users have misinterpreted the display for out of range measurement indicated by the blinking" ---" to mean a zero measurement.	accessdata.fda.gov
March 5, 2014	67677	Class I	Terminated	Draeger Oxylog 3000 plus ventilators, emergency and transport ventilator. Part number: 5704833	The potentiometers (knobs) for setting the ventilation parameters may have contact interrupted and the device discontinues ventilation, gives an audible alarm and displays the error message Poti unplugged.	accessdata.fda.gov
February 7, 2014	67502	Class I	Terminated	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 patients within a hos	The battery capacity of the optional PS500 Power Supply Unit of the Infinity ACS Workstation Critical Care (Evita Infinity V500) did not last as long as expected.	accessdata.fda.gov
December 10, 2013	67056	Class II	Terminated	Draeger Infinity Acute Care System Monitoring Solution	After a test in which a low SpO2 (yellow) medium grade alarm initiated in neo-natal mode and was subsequently paused, the high grade life threatening SpO2 alarm (red) did not activate when the SpO2 values were decreased to reach the red alarm limit.	accessdata.fda.gov
July 2, 2012	62470	Class II	Terminated	Drager PT 4000 Phototherapy System	A routine internal quality check found that the Drager PT 4000 Phototherapy System is fitted with a 16 Amp rated fuse instead of the specified 1.6 Amp rated fuse. This may mean that the internal fuse would not trip promptly in the event of an internal short-circuit. The possible consequence is the wall outlet circuit breaker would trip first on the device ma	accessdata.fda.gov
July 29, 2011	59568	Not yet classified	Terminated	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.	Monitor keys may spontaneously become inoperative or active. This may cause a membrane switch panel malfunction, which could result in the monitor discharging a patient automatically.	accessdata.fda.gov
August 26, 2010	56676	Not yet classified	Terminated	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	potential failures to Electri-Cord Manufacturing AC power cord	accessdata.fda.gov
August 19, 2010	56600	Not yet classified	Terminated	Oxylog 3000, Emergency and Transport Ventilator; Catalog #2M86300; Drager Medical Inc., 3135 Quarry Road, Telford, PA 18969.	Patients received insufficient ventilation. The Oxylog 3000 Instructions are inadequate relating to dead space volume.	accessdata.fda.gov
June 4, 2010	55870	Not yet classified	Terminated	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.	Monitor keys may become inoperative or activate spontaneously, causing a membrane switch panel malfunction. This may discharge a patient automatically.	accessdata.fda.gov
July 29, 2009	52835	Not yet classified	Terminated	Heater Elements for Resuscitaire Infant Radiant Warmers model numbers RW82, RW82 VHA, WBR82, and WMRW82, 120 volt configuration only.	Spark, flame and smoke: A mis-positioned crimp on heater element lead wire resulted in flame and smoke aerating from the top of the warmer assembly.	accessdata.fda.gov
July 17, 2009	52718	Not yet classified	Terminated	Stabilet Infant Warming System, model numbers 200, 300, 1250, 1500, 200/3000, 2000, 2200/3200, 3000, and 3200.	Hot particles fell into the infant bassinet beneath a Radiant Infant Warmer. The resulting fire injured an infant. These devices are obsolete.	accessdata.fda.gov

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Updated January 17, 2025. 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.