510(k) Report

510(k) · Cleared

Cleared

Babytherm 8000 WB

K945467510(k) TraditionalCleared Apr 28, 1995172-day reviewClass II21 CFR 890.5720

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

Drager, Inc. · ILO Pack, Hot Or Cold, Water Circulating

Cleared on Apr 28, 1995 after a 172-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 3 later devices descend from it.

Decided
Apr 28, 1995
Review
172 days
Class
Class II
Product code
ILO
Recalls
None
Predicates
0

3 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 1997: 1 descendant cleared2000: 1 descendant cleared2006: 1 descendant cleared1995200020052010201520202025
  1. This deviceK945467 Babytherm 8000 WBDrager, Inc. · 1995
  2. Descendant · cites it directly · 2 of its ownK971198 Babytherm 8004 Babytherm 8010Drager, Inc. · 1997 · Recalled
  3. Descendant · 2 generations on · 1 of its ownK993051 Versalet 7700 Care Center, Model # 7700Hill-Rom Air-Shields · 2000
  4. Descendant · 3 generations on · 0 of its ownK053399 Versalet 7700 Care CenterDraeger Medical Infant Care, Inc. · 2006

Most influential descendants

Showing 3 of 3 · See all
  • K971198Babytherm 8004 Babytherm 8010Drager, Inc. · 1997 · cites it directly2descendants
  • K993051Versalet 7700 Care Center, Model # 7700Hill-Rom Air-Shields · 2000 · 2 generations on1descendant
  • K053399Versalet 7700 Care CenterDraeger Medical Infant Care, Inc. · 2006 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K945467Babytherm 8000 WBDrager, Inc.1995—
+1K971198Babytherm 8004 Babytherm 8010Drager, Inc.19971
+2K993051Versalet 7700 Care Center, Model # 7700Hill-Rom Air-Shields2000—
+3K053399Versalet 7700 Care CenterDraeger Medical Infant Care, Inc.2006—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
200010
200610
FIG. 1 — Lineage of K945467, 1995–2006Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in ILO? 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 ILO device

  1. #1 K213097 Armory Motionscore 4.7 · 5 generations · no Class I recall
Get a 510(k) Report

What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (3)

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

NumberDeviceApplicantDecidedDescendants
K971198Babytherm 8004 Babytherm 8010Drager, Inc.19972

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

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K971198 (Drager, Inc., 1997) has gone furthest, with 2 descendants of its own.

How does its category compare?

All ILO devices

ILO Pack, Hot Or Cold, Water Circulating: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · ILO

1in 2022

2007: 22008: 12009: 12022: 1
2007high 2 (2007) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · ILO

Too few ILO 510(k)s in any year since 2007 to give a median.

Recalls per year · ILO

1in 2021

2009: 22011: 12013: 82017: 12021: 12026 (partial year): 4
2007high 8 (2013) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · ILO

9in 2025

2007: 142008: 122009: 172010: 1712011: 2412012: 652013: 602014: 492015: 602016: 442017: 432018: 402019: 292020: 72021: 142022: 102023: 122024: 102025: 9
2007high 241 (2011) · low 7 (2020)2025

MAUDE reports naming product code ILO, 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—014
20081—012
20091—217
20100—0171
20110—1241
20120—065
20130—860
20140—049
20150—060
20160—044
20170—143
20180—040
20190—029
20200—07
20210—114
20221—010
20230—012
20240—010
20250—09
20260—4—

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 ILO

The ILO category page

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  • K073675T-Pump Localized Temperature Therapy PumpGaymar Industries, Inc. · 20081 recall
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https://510kreport.com/device/K945467 · printed Nov 5, 2026

Cite this page

510(k) Report. “K945467: Babytherm 8000 WB.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K945467

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026