510(k) Report

FDA applicant

Kirk Specialty Systems

Carrollton, TX4 decisions1993–19960 recalls

FDA records 4 decisions for Kirk Specialty Systems (Carrollton, TX) from 1993 to 1996: 4 510(k) clearances. Most are in product codes BTM (Ventilator, Emergency, Manual (Resuscitator)) and CBP (Valve, Non-Rebreathing). 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, anesthesiology panel, where it files most

How often FDA has decided Kirk Specialty Systems’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Kirk Specialty Systems since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Kirk Specialty Systems 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?

  • BTMVentilator, Emergency, Manual (Resuscitator)2decisions
  • CBPValve, Non-Rebreathing1decision
  • BTRTube, Tracheal (W/Wo Connector)1decision

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.

  • K933626Capno-FloKirk Specialty Systems · 19931cites it

What has FDA decided for it lately?

  • K962098Esophageal Intubation DetectorKirk Specialty Systems · 1996
  • K952512Capno-Flo Regulator, Capno-FloKirk Specialty Systems · 1995
  • K945822Capno-Flo (TM) RegulatorKirk Specialty Systems · 1995
  • K933626Capno-FloKirk Specialty Systems · 1993

All 4 as Kirk Specialty Systems →