510(k) Report

FDA applicant

Save-T-Breath Distributors C.C.

South Africa, ZA3 decisions1994–19940 recalls

FDA records 3 decisions for Save-T-Breath Distributors C.C. (South Africa, ZA) in 1994: 3 510(k) clearances. Most are in product codes JOL (Catheter And Tip, Suction) and CAE (Airway, Oropharyngeal, Anesthesiology). No 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, general hospital panel, where it files most

How often FDA has decided Save-T-Breath Distributors C.C.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Save-T-Breath Distributors C.C. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Save-T-Breath Distributors C.C. 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?

  • JOLCatheter And Tip, Suction1decision
  • CAEAirway, Oropharyngeal, Anesthesiology1decision
  • HFWClamp, Umbilical1decision

What has FDA decided for it lately?

  • K933763Save-T-Breath Ambilical Cord ClampSave-T-Breath Distributors C.C. · 1994
  • K933762STB Yankauer Sucker/NozzleSave-T-Breath Distributors C.C. · 1994
  • K933760STB Guedel AirwaySave-T-Breath Distributors C.C. · 1994

All 3 as Save-T-Breath Distributors C.C. →