510(k) Report

FDA applicant

Respironics Georgia, Inc.

Kennesaw, GA2 decisions2001–20022 recalls

FDA records 2 decisions for Respironics Georgia, Inc. (Kennesaw, GA) from 2001 to 2002: 2 510(k) clearances. Most are in product codes FLS (Monitor, Apnea, Facility Use) and DQA (Oximeter). Its devices cite 1 predicate, 0 of them its own earlier devices. 2 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 Respironics Georgia, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Respironics Georgia, Inc. since 2007.

Recalls per year

1in 2009

2007: 12009: 1
2007high 1 (2007) · low 0 (2008)2026

Class I Class II/III not classified

FIG. 1 — Respironics Georgia, Inc. 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?

  • FLSMonitor, Apnea, Facility Use1decision
  • DQAOximeter1decision

Whose devices does it build on?

Its devices cite 1 predicate; 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.

  • K001708Profox Software, Model 920M-41Respironics Georgia, Inc. · 20012cite it
  • K011597Smartmonitor 2, Model 4000Respironics Georgia, Inc. · 20021cites it

What has FDA decided for it lately?

  • K011597Smartmonitor 2, Model 4000Respironics Georgia, Inc. · 20022 recalls
  • K001708Profox Software, Model 920M-41Respironics Georgia, Inc. · 2001

All 2 as Respironics Georgia, Inc. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K011597SmartMonitor 2 Infant Apnea Monitor. The monitor is intended for use in the continuous…Apr 23, 2009
  • K011597Lead Wire Pin/Socket 24 in 1 pr model number 9520. Filter, mask, and/or accessories for…Oct 15, 2007

Other applicant names beginning “Respironics”

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

Respironics, Inc. 174Respironics Inc., Sleep & Home Respiratory Group 21Respironics California, Inc. 11Respironics Novametrix, Inc. 11Respironics New Jersey, Inc. 5Respironics Respiratory Drug Delivery (Uk), Ltd. 2Respironics Healthscan, Inc. 2Respironics Inc. (Dba Philips Respironics) 1Respironics (Ireland) Limited 1