FDA applicant

Respironics Healthscan, Inc.

Great Neck, NY2 decisions2001–20030 recalls

FDA records 2 decisions for Respironics Healthscan, Inc. (Great Neck, NY) from 2001 to 2003: 2 510(k) clearances. Most are in product codes CAF (Nebulizer (Direct Patient Interface)) and BTI (Compressor, Air, Portable). Its devices cite 2 predicates, 0 of them its own earlier devices. 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 Respironics Healthscan, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

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

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Respironics Healthscan, 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

Other applicant names beginning “Respironics”

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

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

Respironics Healthscan, Inc.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Respironics”