510(k) Report

FDA applicant

Smiths Medical

Hythe, Kent, GB3 decisions2004–20191 recall

FDA records 3 decisions for Smiths Medical (Hythe, Kent, GB) from 2004 to 2019: 3 510(k) clearances. Most are in product codes BWC (Needle, Emergency Airway) and JOH (Tube Tracheostomy And Tube Cuff). Its devices cite 14 predicates, 0 of them its own earlier devices. 1 recall is linked to its devices.

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

FDA decisions per year

1in 2019

2019: 1
2007high 1 (2019) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2021

2021: 1
2007high 1 (2021) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Smiths 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?

  • BWCNeedle, Emergency Airway1decision
  • JOHTube Tracheostomy And Tube Cuff1decision
  • BWFSpirometer, Therapeutic (Incentive)1decision

Whose devices does it build on?

Its devices cite 14 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 0 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.

  • K041348Portex Ultraperc Percutaneous Dilation Tracheostomy Kit_with Serial Dilators or Single Stage Dilator, Blue…Smiths Medical · 20043cite it

What has FDA decided for it lately?

  • K181660Acapella Choice Blue Vibratory PEP DeviceSmiths Medical · 2019
  • K050166Portex Emergency Cricothyroidotomy KitSmiths Medical · 2005
  • K041348Portex Ultraperc Percutaneous Dilation Tracheostomy Kit_with Serial Dilators or Single Stage Dilator, Blue…Smiths Medical · 20041 recall

All 3 as Smiths Medical →

What has been recalled?

1 recall linked to its devices; the latest:

  • K041348PORTEX UNLTRperc Percutaneous Dilation Tracheostomy Kit, REF 100/596/090 - Product…May 14, 2021Class II

Other applicant names beginning “Smiths”

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

Smiths Medical Asd, Inc. 53Smiths Industries Medical Systems, Inc. 23Smiths Medical MD, Inc. 20Smiths Medical Pm, Inc. 5Smiths Medical International, Ltd. 4Smiths Medical Ads, Inc. 2Smiths Medical International Ltd., Luton 1