510(k) Report

FDA applicant

Ati Medical, Inc.

Las Vegas, NV2 decisions1991–20020 recalls

FDA records 2 decisions for Ati Medical, Inc. (Las Vegas, NV) from 1991 to 2002: 2 510(k) clearances. Most are in product codes BXB (Exerciser, Powered) and KXK (Source, Brachytherapy, Radionuclide). Its devices cite 3 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, physical medicine panel, where it files most

How often FDA has decided Ati Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Ati Medical, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Ati Medical, 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?

  • BXBExerciser, Powered1decision
  • KXKSource, Brachytherapy, Radionuclide1decision

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K020683Isorod PD-103 Implant, Model Ati-PD-103Ati Medical, Inc. · 2002
  • K910026Ati Medical Comfort Plus CPM PadAti Medical, Inc. · 1991

All 2 as Ati Medical, Inc. →