510(k) Report

FDA applicant

Enviracaire Corp.

Hagerstown, MD1 decision1987–19870 recalls

FDA records 1 decision for Enviracaire Corp. (Hagerstown, MD) in 1987: 1 510(k) clearance. All are in product code FRF (Cleaner, Air, Medical Recirculating). 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 Enviracaire Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Enviracaire Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Enviracaire Corp. 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?

  • FRFCleaner, Air, Medical Recirculating1decision

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.

  • K872359Enviracaire Model EV-1Enviracaire Corp. · 19871cites it

What has FDA decided for it lately?

  • K872359Enviracaire Model EV-1Enviracaire Corp. · 1987

The one decision as Enviracaire Corp. →