FDA applicant

Lerner Medical, Inc.

Lansdale, PA1 decision1997–19970 recalls

FDA records 1 decision for Lerner Medical, Inc. (Lansdale, PA) in 1997: 1 510(k) clearance. All are in product code GCJ (Laparoscope, General & Plastic Surgery). Its devices cite 1 predicate, 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 Lerner Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

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

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Lerner Medical, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Other applicant names beginning “Lerner”

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

Lerner Laboratories, Inc. 5 Lerner Medical Devices, Inc. 3

Lerner Medical, Inc.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Lerner”