FDA applicant

Mighty Oak Medical, Inc.

Englewood, CO10 decisions2015–20260 recalls

FDA records 10 decisions for Mighty Oak Medical, Inc. (Englewood, CO) from 2015 to 2026: 10 510(k) clearances. Most are in product codes PQC (Pedicle Screw Placement Guide) and QIH (Automated Radiological Image Processing Software). Since 2016 its 510(k)s took a median of 142 days from receipt to decision, against 136 for FDA’s reviews in the same codes and years. Its devices cite 13 predicates, 7 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Mighty Oak Medical”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, orthopedic panel, where it files most

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

FDA decisions per year

2in 2025

2015high 2 (2018) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2015.

FIG. 1 — Mighty Oak Medical, Inc. by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Mighty Oak 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 “Mighty”

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

Mighty Mo, Corp. 1

Mighty Oak Medical, Inc.

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 “Mighty”