510(k) Report

FDA applicant

Healthway Products, Inc.

Syracuse, NY1 decision2002–20021 recall

FDA records 1 decision for Healthway Products, Inc. (Syracuse, NY) in 2002: 1 510(k) clearance. All are in product code FRF (Cleaner, Air, Medical Recirculating). 1 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 Healthway Products, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

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

Recalls per year

1in 2012

2012: 1
2007high 1 (2012) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Healthway Products, 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

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.

  • K012549Advanced Air Purification System; Hepa Air Cleaning SystemHealthway Products, Inc. · 20021cites it

What has FDA decided for it lately?

  • K012549Advanced Air Purification System; Hepa Air Cleaning SystemHealthway Products, Inc. · 20021 recall

The one decision as Healthway Products, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K012549Product is a 15x16x27" (WxDxH) air purifier device with one of two different brands next…Jan 9, 2012