510(k) Report

FDA applicant

Ohmeda Medical

Madison, WI120 decisions1984–201376 recalls

FDA records 120 decisions for Ohmeda Medical (Madison, WI) from 1984 to 2013: 119 510(k) clearances and 1 De Novo grant. Most are in product codes BSZ (Gas-Machine, Anesthesia) and FMZ (Incubator, Neonatal). Its devices cite 35 predicates, 21 of them its own earlier devices. 76 recalls are linked to its devices, 14 Class I.

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

FIG. A — Illustration, anesthesiology panel, where it files most

How often FDA has decided Ohmeda Medical’s devices, and how often a recall has named them.

FDA decisions per year

1in 2013

2007: 42009: 12010: 22013: 1
2007high 4 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

5in 2026

2008: 12012: 3, 3 Class I2013: 10, 4 Class I2014: 42016: 112017: 12018: 52019: 3, 3 Class I2020: 32022: 112023: 2, 1 Class I2024: 1, 1 Class I2025: 12026 (partial year): 5, 2 Class I
2007high 11 (2016) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Ohmeda Medical by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • BSZGas-Machine, Anesthesia17decisions
  • FMZIncubator, Neonatal15decisions
  • FMTWarmer, Infant Radiant10decisions
  • CBKVentilator, Continuous, Facility Use10decisions
  • CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase6decisions
  • DQAOximeter5decisions

Also: CBQ (4), BZK (4), FMG (4), LBI (3), FOZ (3), CAD (3).

Whose devices does it build on?

Its devices cite 35 predicates; 21 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 82 times; 21 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K962127Ohmeda 3800 Pulse OximeterOhmeda Medical · 19967cite it
  • K993407Ohmeda Medical OmnibedOhmeda Medical · 20006cite it
  • K942091Ohmeda Tec 5 Vaporizer for Use with SevofluraneOhmeda Medical · 19955cite it
  • K070210Giraffe and Panda T- Piece Resuscitation SystemOhmeda Medical · 20075cite it
  • K880572Ohmeda 2350 Finapres (R) Blood Pressure MonitorOhmeda Medical · 19884cite it
  • K070377Giraffe and Panda WarmerOhmeda Medical · 20073cite it

What has FDA decided for it lately?

  • K123309Giraffe and Panda WarmersOhmeda Medical · 20133 Class I recalls
  • K101788Giraffe OmnibedOhmeda Medical · 20103 Class I recalls
  • K101778Giraffe IncubatorOhmeda Medical · 20101 Class I recall
  • K090697Modification to: Giraffe and Panda WarmerOhmeda Medical · 20091 Class I recall
  • K072157Modification to Giraffe and Panda Warmers (Giraffe and Panda Uninterruptible Power Supply)Ohmeda Medical · 20071 recall
  • K070377Giraffe and Panda WarmerOhmeda Medical · 20071 Class I recall
  • K070247Giraffe and Panda Bag and Mask Resuscitation SystemOhmeda Medical · 20073 Class I recalls
  • K070210Giraffe and Panda T- Piece Resuscitation SystemOhmeda Medical · 20073 Class I recalls

All 120 as Ohmeda Medical →

What has been recalled?

76 recalls linked to its devices; the latest:

  • K974083BD Connecta" BD Luer-Lok" 360 REF 394910 UDI-DI code: 00382903949106 BD Connecta"…May 21, 2026Class II
  • K123309Panda Freestanding Warmer, Infant Radiant Warmer Product Identifiers: 2063568-001…May 8, 2026Class I
  • K070247Giraffe Stand-alone Infant Resuscitation System; Powered emergency ventilator…May 8, 2026Class I
  • K020543Giraffe OmniBed, a combination of an infant incubator and an infant warmer, All ModelsMay 1, 2026Class II
  • K020543Giraffe OmniBed Field Replaceable Unit (FRU), Model Numbers 6600-1056-400 and…May 1, 2026Class II
  • K974083BD Connecta BD Luer-Lok 360, REF 394910 UDI-DI code: 00382903949106 Connecta¿ Plus 1 and…Feb 20, 2025Class II

Other applicant names beginning “Ohmeda”

FDA records each applicant name separately; these may or may not be the same firm.

Ohmeda Medical, A Division of Datex-Ohmeda, Inc. 3Ohmeda Anesthesia Systems Therapy Group 2Ohmeda Medical, A Division of Datex-Ohmeda,Inc. A GE… 1Ohmeda Monitoring Systems 1