FDA applicant

Mesa Laboratories, Inc.

Lakewood, CO9 decisions2004–20201 recall

FDA records 9 decisions for Mesa Laboratories, Inc. (Lakewood, CO) from 2004 to 2020: 9 510(k) clearances. Most are in product codes FRC (Indicator, Biological Sterilization Process) and FKH (Solution-Test Standard-Conductivity, Dialysis). Its devices cite 10 predicates, 3 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, gastroenterology and urology panel, where it files most

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

FDA decisions per year

1in 2020

2007high 2 (2013) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2017

2007high 1 (2017) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Mesa Laboratories, 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 “Mesa”

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

Mesa Medical, Inc. 7 Mesa Biotech, Inc. 3

Mesa Laboratories, 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 “Mesa”