510(k) Report

FDA applicant

Southmedic, Inc.

Barrie, Ontario Canada, CA10 decisions1984–20233 recalls

FDA records 10 decisions for Southmedic, Inc. (Barrie, Ontario Canada, CA) from 1984 to 2023: 10 510(k) clearances. Most are in product codes CAD (Vaporizer, Anesthesia, Non-Heated) and CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase). Its devices cite 8 predicates, 0 of them its own earlier devices. 3 recalls are 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 Southmedic, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2011: 12014: 12023: 1
2007high 1 (2011) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2017

2017: 1
2007high 1 (2017) · low 0 (2007)2026

Class I Class II/III not classified

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

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

See the 510(k) Report

Which product codes does it file in?

  • CADVaporizer, Anesthesia, Non-Heated5decisions
  • CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase3decisions
  • BZAConnector, Airway (Extension)1decision
  • CAFNebulizer (Direct Patient Interface)1decision

Whose devices does it build on?

Its devices cite 8 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K945993VapofilSouthmedic, Inc. · 19951cites it

What has FDA decided for it lately?

  • K222511Oxy2ProSouthmedic, Inc. · 2023
  • K131410CO2/O2 Nasal Cannula (with 4 (10CM) O2 and CO2 Tube), CO2/O2 Nasal Cannula (with 8 (240CM) O2 and 4 (10CM)…Southmedic, Inc. · 2014
  • K101953SMDIA-1000Southmedic, Inc. · 2011
  • K014211Oxyarm CO2Southmedic, Inc. · 20021 recall
  • K945993VapofilSouthmedic, Inc. · 19952 recalls
  • K923265Funnel AdaptorSouthmedic, Inc. · 1993
  • K863318Aerosol-TSouthmedic, Inc. · 1986
  • K861839VapofilSouthmedic, Inc. · 1986

All 10 as Southmedic, Inc. →

What has been recalled?

3 recalls linked to its devices; the latest:

  • K014211Southmedic Oxygen Masks with EtCO2 sampling line part number OM-2125-8, 25 masks per…Oct 17, 2017Class II
  • K945993Vapofils with Stainless Steel Block Ends, Item Number V0507F (Isoflurane). The vapofil…Apr 21, 2006
  • K945993Vapofils with Stainless Steel Block Ends, Item Number V0507S (Sevofluane). The vapofil…Apr 21, 2006