510(k) Report

FDA applicant

Respan Products, Inc.

Lewiston, NY1 decision1994–19940 recalls

FDA records 1 decision for Respan Products, Inc. (Lewiston, NY) in 1994: 1 510(k) clearance. All are in product code BYG (Mask, Oxygen). 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 Respan Products, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Respan Products, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Respan Products, 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?

  • BYGMask, Oxygen1decision

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.

  • K942907Jemsdal MaskRespan Products, Inc. · 19941cites it

What has FDA decided for it lately?

  • K942907Jemsdal MaskRespan Products, Inc. · 1994

The one decision as Respan Products, Inc. →