FDA applicant

Paragon Medical

Pierceton, IN5 decisions2003–20190 recalls

FDA records 5 decisions for Paragon Medical (Pierceton, IN) from 2003 to 2019: 5 510(k) clearances. All are in product code KCT (Sterilization Wrap Containers, Trays…). Since 2016 its 510(k)s took a median of 127 days from receipt to decision, against 187 for FDA’s reviews in the same codes and years. Its devices cite 6 predicates, 2 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Paragon Medical, Inc.”.

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 Paragon Medical’s devices, and how often a recall has named them.

FDA decisions per year

2in 2019

2007high 2 (2019) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Paragon Medical’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 “Paragon”

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

Paragon 28, Inc. 61 Paragon Vision Sciences 16 Paragon Trade Brands, Inc. 14 Paragon Diagnostics, Inc. 7 Paragon Implant Mfg., LLC 5 Paragon Optical Co. 2 Paragon Medical and Scientific, Inc. 1 Paragon Bioteck, Inc. 1

Paragon Medical

Which product codes does it file in?

How long do its 510(k) reviews take?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Paragon”