FDA applicant

Techno-Path Manufacturing, Ltd.

Highland Village, TX7 decisions2013–20252 recalls

FDA records 7 decisions for Techno-Path Manufacturing, Ltd. (Highland Village, TX) from 2013 to 2025: 7 510(k) clearances. Most are in product codes JJY (Multi-Analyte Controls, All Kinds (Assayed)) and DIF (Drug Mixture Control Materials). Its devices cite 7 predicates, 1 of them its own earlier devices. 2 recalls are linked to its devices.

FDA’s records also spell it “Techno-Path Manufacturing”.

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 Techno-Path Manufacturing, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2013high 5 (2013) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

2in 2019

2013high 2 (2019) · low 0 (2013)2026

Class I Class II/III not classified

FIG. 1 — Techno-Path Manufacturing, Ltd. by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Techno-Path Manufacturing, Ltd.’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 “Techno-Path”

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

Techno Ophthalmics Intl. 1

Techno-Path Manufacturing, Ltd.

Which product codes does it file in?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Techno-Path”