510(k) Report

FDA applicant

Smiths Medical International, Ltd.

Waukesha, WI4 decisions2005–20138 recalls

FDA records 4 decisions for Smiths Medical International, Ltd. (Waukesha, WI) from 2005 to 2013: 4 510(k) clearances. Most are in product codes BTL (Ventilator, Emergency, Powered (Resuscitator)) and BTO (Tube, Tracheostomy (W/Wo Connector)). Its devices cite 7 predicates, 1 of them its own earlier devices. 8 recalls are linked to its devices, 6 Class I.

FDA’s records also spell it “Smiths Medical International”.

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 International, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2013

2007: 12013: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

6in 2024

2007: 12021: 12024: 6, 6 Class I
2007high 6 (2024) · low 0 (2008)2026

Class I Class II/III not classified

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

Planning a device like Smiths Medical International, Ltd.’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?

  • BTLVentilator, Emergency, Powered (Resuscitator)3decisions
  • BTOTube, Tracheostomy (W/Wo Connector)1decision

Whose devices does it build on?

Its devices cite 7 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 times; 1 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.

  • K060945Portex Percutaneous Tracheostomy KitSmiths Medical International · 20062cite it
  • K051322Pneupac Vri Standard, Model Vristdnus, Pneupac Vri Responder, Model VriresnusSmiths Medical International, Ltd. · 20052cite it

What has FDA decided for it lately?

  • K123957Pneupac Parapac PlusSmiths Medical International, Ltd. · 20136 Class I recalls
  • K071527Pneupac VR1 Air MixSmiths Medical International, Ltd. · 2007
  • K060945Portex Percutaneous Tracheostomy KitSmiths Medical International · 2006
  • K051322Pneupac Vri Standard, Model Vristdnus, Pneupac Vri Responder, Model VriresnusSmiths Medical International, Ltd. · 20051 recall

All 3 as Smiths Medical International, Ltd. →The one decision as Smiths Medical International →

What has been recalled?

8 recalls linked to its devices; the latest:

  • K123957paraPAC plus 310 ventilator kit with internal PEEP and CPAP, Item Number P310NMay 31, 2024Class I
  • K123957paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300NMay 31, 2024Class I
  • K123957Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NXXMay 31, 2024Class I
  • K123957Pneupac paraPAC plus 300 ventilator kit, REF P300NXXMay 31, 2024Class I
  • K123957smiths medical Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NUSFeb 7, 2024Class I
  • K123957smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUSFeb 7, 2024Class I

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 3Smiths Medical Ads, Inc. 2Smiths Medical International Ltd., Luton 1