FDA applicant

Polymed Therapeutics, Inc.

Mission Viejo, CA5 decisions2012–20141 recall

FDA records 5 decisions for Polymed Therapeutics, Inc. (Mission Viejo, CA) from 2012 to 2014: 5 510(k) clearances. Most are in product codes JHI (Visual, Pregnancy Hcg, Prescription Use) and LCX (Kit, Test, Pregnancy, Hcg, Over The Counter). Its devices cite 11 predicates, 0 of them its own earlier devices. 1 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, clinical chemistry panel, where it files most

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

FDA decisions per year

2in 2014

2012high 2 (2013) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

1in 2016

2012high 1 (2016) · low 0 (2012)2026

Class I Class II/III not classified

FIG. 1 — Polymed Therapeutics, Inc. by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Polymed Therapeutics, 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 “Polymed”

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

Polymed Laboratories 2 Polymed (Xiamen) Plastic Industrial Co., Ltd. 1

Polymed Therapeutics, Inc.

Which product codes does it file in?

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?

What has been recalled?

Other applicant names beginning “Polymed”