FDA applicant

Lexington Medical, Inc.

Billerica, MA9 decisions2017–20250 recalls

FDA records 9 decisions for Lexington Medical, Inc. (Billerica, MA) from 2017 to 2025: 9 510(k) clearances. Most are in product codes GDW (Staple, Implantable) and GAG (Stapler, Surgical). Since 2016 its 510(k)s took a median of 91 days from receipt to decision, against 92 for FDA’s reviews in the same codes and years. Its devices cite 9 predicates, 5 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, general and plastic surgery panel, where it files most

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

FDA decisions per year

1in 2025

2017high 3 (2018) · low 0 (2021)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2017.

FIG. 1 — Lexington Medical, Inc. by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Lexington 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

Other applicant names beginning “Lexington”

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

Lexington International, LLC 8 Lexington Industries 2 Lexington Instruments 1

Lexington Medical, Inc.

Which product codes does it file in?

How long do its 510(k) reviews take?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Lexington”