510(k) Report

FDA applicant

Providence Medical Technology, Inc.

Pleasanton, CA21 decisions2012–20261 recall

FDA records 21 decisions for Providence Medical Technology, Inc. (Pleasanton, CA) from 2012 to 2026: 21 510(k) clearances. Most are in product codes MRW (System, Facet Screw Spinal Device) and HRX (Arthroscope). Since 2016 its 510(k)s took a median of 78 days from receipt to decision, against 105 for FDA’s reviews in the same codes and years. Its devices cite 45 predicates, 18 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, orthopedic panel, where it files most

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

FDA decisions per year

3in 2025

2012: 12013: 12016: 12017: 42018: 12019: 22021: 12022: 12023: 22024: 22025: 32026 (partial year): 2
2012high 4 (2017) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

1in 2019

2019: 1
2012high 1 (2019) · low 0 (2012)2026

Class I Class II/III not classified

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

Planning a device like Providence Medical Technology, 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 “Providence”

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