510(k) Report

510(k) · Cleared

Recalled · Class II · 2016

Babytherm 8004 Babytherm 8010

K971198510(k) TraditionalCleared Oct 3, 1997186-day reviewClass II21 CFR 880.5130Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Drager, Inc. · FMT Warmer, Infant Radiant

Cleared on Oct 3, 1997 as substantially equivalent to K945467 (Drager, Inc., 1995) and 3 other predicates after a 186-day review. Its family tree reaches back 1 generation to 1991. 2 later devices descend from it. It has been recalled once.

Decided
Oct 3, 1997
Review
186 days
Class
Class II
Product code
FMT
Recalls
1
Predicates
4

Its longest line of descent runs back 1 generation to K912908 (1991). 4 ancestors in all. 2 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1996: 1 other ancestor1995: 2 other ancestors2000: 1 descendant cleared2006: 1 descendant clearedK912908 · Air-Shields Micro-Lite Phototherapy System · Air-Shields Vickers, Inc. · 19911990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors 1 generation forward: 1 descendant2 generations forward: 1 descendant K912908 · Air-Shields Micro-Lite Phototherapy System · Air-Shields Vickers, Inc. · 19910
  1. Root · 1 generation backK912908 Air-Shields Micro-Lite Phototherapy SystemAir-Shields Vickers, Inc. · 1991
  2. This deviceK971198 Babytherm 8004 Babytherm 8010Drager, Inc. · 1997
  3. Descendant · cites it directly · 1 of its ownK993051 Versalet 7700 Care Center, Model # 7700Hill-Rom Air-Shields · 2000
  4. Descendant · 2 generations on · 0 of its ownK053399 Versalet 7700 Care CenterDraeger Medical Infant Care, Inc. · 2006

Most influential descendants

Showing 2 of 2 · See all
  • K993051Versalet 7700 Care Center, Model # 7700Hill-Rom Air-Shields · 2000 · cites it directly1descendant
  • K053399Versalet 7700 Care CenterDraeger Medical Infant Care, Inc. · 2006 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K912908Air-Shields Micro-Lite Phototherapy SystemAir-Shields Vickers, Inc.1991—
0 (this device)K971198Babytherm 8004 Babytherm 8010Drager, Inc.1997—
+1K993051Versalet 7700 Care Center, Model # 7700Hill-Rom Air-Shields2000—
+2K053399Versalet 7700 Care CenterDraeger Medical Infant Care, Inc.2006—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199520
199610

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200010
200610
FIG. 1 — Lineage of K971198, 1991–2006Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in FMT? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new FMT device

  1. #1 K243606 Babyroo TN300score 9.3 · 3 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (4)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K945467Babytherm 8000 WB
Summary page 2
…are treated in incubators or Drédger Drdger Radiant | Drdger AirShields Driger Babytherm 8000 WB Heater RH 600 | PT4000 Microlite™ Babytherm 8004 / 8010 510(k) Number K 94 5467 K 95 3489 K 95 4611 K 91 2908 Intended Use Heated bassinet intended | Radiant warmer | PT 4000 is used |Phototherapy for | Babyt…
Drager, Inc.1995—
*K953489Drager Infant Radiant Warmern RH600
Summary page 2
…ed in incubators or Drédger Drdger Radiant | Drdger AirShields Driger Babytherm 8000 WB Heater RH 600 | PT4000 Microlite™ Babytherm 8004 / 8010 510(k) Number K 94 5467 K 95 3489 K 95 4611 K 91 2908 Intended Use Heated bassinet intended | Radiant warmer | PT 4000 is used |Phototherapy for | Babytherm 8004…
Drager, Inc.1996—
*K954611Drager PT4000 Phototherapy System
Summary page 2
…bators or Drédger Drdger Radiant | Drdger AirShields Driger Babytherm 8000 WB Heater RH 600 | PT4000 Microlite™ Babytherm 8004 / 8010 510(k) Number K 94 5467 K 95 3489 K 95 4611 K 91 2908 Intended Use Heated bassinet intended | Radiant warmer | PT 4000 is used |Phototherapy for | Babytherm 8004 / 8010 is…
Drager, Inc.19951
*K912908Air-Shields Micro-Lite Phototherapy System
Summary page 2
…Drédger Drdger Radiant | Drdger AirShields Driger Babytherm 8000 WB Heater RH 600 | PT4000 Microlite™ Babytherm 8004 / 8010 510(k) Number K 94 5467 K 95 3489 K 95 4611 K 91 2908 Intended Use Heated bassinet intended | Radiant warmer | PT 4000 is used |Phototherapy for | Babytherm 8004 / 8010 is an infant…
Air-Shields Vickers, Inc.1991—

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K993051Versalet 7700 Care Center, Model # 7700Hill-Rom Air-Shields20001

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Jun 22, 2016Class IIZ-2295-2016Nonconforming Material/ComponentRisk associated with operating the device in skin temperature mode with temperature sensors attached but no patient connected.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • 1 of the 4 ancestors has a recall of any class.
  • Of its descendants, K993051 (Hill-Rom Air-Shields, 2000) has gone furthest, with 1 descendant of its own.

How does its category compare?

All FMT devices

FMT Warmer, Infant Radiant: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FMT

1in 2025

2007: 22009: 12010: 12011: 12012: 42013: 12018: 12020: 22021: 12022: 12023: 12025: 1
2007high 4 (2012) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FMT

103in 2012

2012: 103 days median
2007high 103 (2012)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FMT

4in 2019

2008: 12009: 22013: 22014: 12015: 12016: 12018: 42019: 4, 4 Class I2026 (partial year): 2, 2 Class I
2007high 4 (2018) · low 0 (2007)2026

Class I (6 since 2007) Class II/III not classified

Adverse event reports per year · FMT

359in 2025

2007: 212008: 1142009: 802010: 1062011: 792012: 542013: 552014: 792015: 562016: 562017: 462018: 792019: 1,4372020: 1,6052021: 4732022: 1532023: 1752024: 2572025: 359
2007high 1,605 (2020) · low 21 (2007)2025

MAUDE reports naming product code FMT, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20072—021
20080—1114
20091—280
20101—0106
20111—079
20124103054
20131—255
20140—179
20150—156
20160—156
20170—046
20181—479
20190—4 (4)1,437
20202—01,605
20211—0473
20221—0153
20231—0175
20240—0257
20251—0359
20260—2 (2)—

What is it indicated for?

Babytherm 8004 / 8010 is an infant warmer system intended as a therapeutic device providing warmth for premature and full-term neonates and infants with a weight up to 16 Ibs. It is intended for use in delivery rooms, operating theatres, maternity and obstetric units, neonatal wards, neonatal and paediatric intensive care units.

Both Systems can be equipped with the optional phototherapy system for treatment of Hyperbilirubinemia.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Drager, Inc.

20 FDA decisions under this applicant name. See the company

  • K992608Atc Option for Evita 2 Dura and Evita 4Drager, Inc. · 1999
  • K984577Drager Oxylog 2000Drager, Inc. · 1999
  • K983219Neoflow Option Model Numbers 8413563, 8411900Drager, Inc. · 1998
  • K982789Medical Air Compressor, Model # 8413419Drager, Inc. · 19981 recall
  • K980642EVITA 4 (8411900)Drager, Inc. · 1998

Recent decisions in FMT

The FMT category page

  • K243606Babyroo TN300Draeger Medical Systems, Inc. · 2025
  • K230278Babyroo TN300Draeger Medical Systems, Inc. · 2023
  • K213551Giraffe Omnibed Carestation CS1Datex Ohmeda, Inc. · 20222 Class I recalls
  • K201628Panda iRes Warmer, Giraffe WarmerGE Healthcare · 20211 Class I recall
  • K200319HYDRO-TEMP Neonatal Skin Surface Temperature Sensor, HYDRO-TEMP Neonatal Skin Surface Temperature Sensor…Deroyal Industries, Inc. · 2020

https://510kreport.com/device/K971198 · printed Nov 4, 2026

Cite this page

510(k) Report. “K971198: Babytherm 8004 Babytherm 8010.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K971198

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026