510(k) Report

FDA applicant

Elite Medical, Inc.

Atlanta, GA1 decision2011–20110 recalls

FDA records 1 decision for Elite Medical, Inc. (Atlanta, GA) in 2011: 1 510(k) clearance. All are in product code LNS (Lithotriptor, Extracorporeal Shock-Wave…). 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, gastroenterology and urology panel, where it files most

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

FDA decisions per year

1in 2011

2011: 1
2011high 1 (2011) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2011.

FIG. 1 — Elite Medical, Inc. by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Elite 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?

  • LNSLithotriptor, Extracorporeal Shock-Wave, Urological1decision

Whose devices does it build on?

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

Who builds on its devices?

Later devices cite its devices 2 times; 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.

  • K101482EM-9000Elite Medical, Inc. · 20112cite it

What has FDA decided for it lately?

  • K101482EM-9000Elite Medical, Inc. · 2011

The one decision as Elite Medical, Inc. →

Other applicant names beginning “Elite”

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

Elite Diagnostic, Ltd. 5Elite Technology, Inc. 5Elite Surgical Supplies (Pty), Ltd. 4Elite International, Inc. 4Elite Electromedical 1Elite Biomedical Solutions 1Elite Medical Supply of New York, LLC 1