Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Applied Medical Resources Corporation · Predicate Candidate Screening

12 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

102 daysmedian FDA review time
357 days90th percentile
12clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K260982Alexis lighted wound protector-retractor, flexible, extra smApplied Medical Resources Corporation2026-04-24300
K253531Alexis® Lighted Wound Protector-Retractor, Rigid, Medium (CLApplied Medical Resources Corporation2026-02-231020
K252412Voyant® Electrosurgical Generator (EA030/Electrosurgical GenApplied Medical Resources Corporation2025-10-31910
K232880Inzii Ripstop Redeployable Retrieval SystemApplied Medical Resources Corporation2023-11-01440
K222284Voyant Maryland Fusion device with Single-Step Activation (EApplied Medical Resources Corporation2022-10-14740
K220969GelPOINT V-Path Vaginal Access SystemApplied Medical Resources Corporation2022-09-161650
K211043Alexis Contained Extraction SystemApplied Medical Resources Corporation2022-03-313570
K202049Python Catheter/Over-the-Wire Latis Graft Cleaning CatheterApplied Medical Resources Corporation2021-09-074100
K190331Applied Medical Laparoscopic Linear CutterApplied Medical Resources Corporation2019-11-222810
K180699Voyant Open Fusion DeviceApplied Medical Resources Corporation2018-04-13280
K172624Voyant 5mm Fusion DeviceApplied Medical Resources Corporation2018-02-131650
K171684Epix Electrosurgical Probe with Smoke EvacuationApplied Medical Resources Corporation2017-08-07610

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda