510(k) Report

FDA applicant

Hamilton Medical AG

Bonaduz, CH45 decisions1985–202135 recalls

FDA records 45 decisions for Hamilton Medical AG (Bonaduz, CH) from 1985 to 2021: 45 510(k) clearances. Most are in product codes CBK (Ventilator, Continuous, Facility Use) and BZR (Mixer, Breathing Gases, Anesthesia Inhalation). Since 2016 its 510(k)s took a median of 302 days from receipt to decision, against 280 for FDA’s reviews in the same codes and years. Its devices cite 82 predicates, 36 of them its own earlier devices. 35 recalls are linked to its devices, 14 Class I.

FDA’s records also spell it “Hamilton Medical, Inc.”.

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 Hamilton Medical AG’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2007: 22008: 22009: 12010: 12011: 22012: 52013: 22015: 12016: 32017: 22019: 12020: 22021: 1
2007high 5 (2012) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

1in 2026

2011: 12012: 2, 1 Class I2013: 12014: 1, 1 Class I2015: 42016: 22017: 12018: 42019: 1, 1 Class I2021: 12022: 2, 1 Class I2023: 9, 8 Class I2024: 1, 1 Class I2025: 1, 1 Class I2026 (partial year): 1
2007high 9 (2023) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Hamilton Medical AG’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • CBKVentilator, Continuous, Facility Use35decisions
  • BZRMixer, Breathing Gases, Anesthesia Inhalation2decisions
  • BTTHumidifier, Respiratory Gas, (Direct Patient Interface)2decisions
  • BSKCuff, Tracheal Tube, Inflatable1decision
  • GBXCatheter, Irrigation1decision
  • BZDVentilator, Non-Continuous (Respirator)1decision

Also: BTI (1), BZO (1).

How long do its 510(k) reviews take?

Since 2016, its 9 510(k)s took a median of 302 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 280 days; 3 of its 9 were faster than that.

Whose devices does it build on?

Its devices cite 82 predicates; 36 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 56 times; 36 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.

  • K061090Galileo Gold AsvHamilton Medical AG · 20064cite it
  • K150893IntelliCuffHamilton Medical AG · 20164cite it
  • K001686Galileo VentilatorHamilton Medical, Inc. · 20004cite it
  • K103803Hamilton-G5Hamilton Medical AG · 20113cite it
  • K040574Galileo GoldHamilton Medical, Inc. · 20043cite it
  • K120670Hamilton-T1Hamilton Medical AG · 20123cite it

What has FDA decided for it lately?

  • K201306Hamilton-C3Hamilton Medical AG · 20211 Class I recall
  • K201658Hamilton-C6Hamilton Medical AG · 20203 Class I recalls
  • K193228Hamilton-G5Hamilton Medical AG · 2020
  • K181216Hamilton-T1, Hamilton-C1Hamilton Medical AG · 20195 Class I recalls
  • K163283Hamilton-H900, Hamilton-BC8010, Hamilton-BC4010Hamilton Medical AG · 20171 recall
  • K161450Hamilton-C3Hamilton Medical AG · 20172 recalls
  • K153046Hamilton-MR1Hamilton Medical AG · 20161 Class I recall
  • K152029Hamilton-H900, Hamilton-BC8022, Hamilton-BC4022, Hamilton-BC8010, Hamilton-BC4010Hamilton Medical AG · 2016

All 30 as Hamilton Medical AG →All 15 as Hamilton Medical, Inc. →

What has been recalled?

35 recalls linked to its devices; the latest:

  • K150893IntelliCuff, Portable automatic cuff pressure controller REF: 951001May 22, 2026Class II
  • K201658Hamilton C6 REF 160021 (ESM Board PN 10144626 UDI-DI code: 76300028PN160021ZW Hamilton…Jun 3, 2025Class I
  • K201658Ventilator HAMILTON-C6, PN: 160021May 15, 2024Class I
  • K153046Hamilton-MR1, REF: 161010, Intensive Care VentilatorJul 26, 2023Class I
  • K181216Hamilton-C1, REF: 161001, Portable Intensive Care VentilatorJul 26, 2023Class I
  • K181216Hamilton-T1, REF: 161006, Intensive Care and Transport VentilatorJul 26, 2023Class I

Other applicant names beginning “Hamilton”

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

Hamilton Co. 16Hamilton Thorne, Inc. 6Hamilton Industries, Inc. 5Hamilton Thorne Research 5Hamilton Thorne Biosciences 3Hamilton Kent 1