Atlas FDA

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

QPC · Predicate Candidate Screening

10 FDA 510(k) clearances under this product code; the 50 most recent screened below.

236 daysmedian FDA review time
515 days90th percentile
10clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K252940VR® Personal Protective Level 3 Gown (VR Gowns)PolyConversions, Inc.2025-12-16920
K242689AAMI Level 4 Protective; GownAzac Group2025-01-131290
K233526Medline Open-back Level 3 Protective GownMedline Industries, LP2024-03-051250
K230384PolyWear® Personal Protective Level 3 GownPolyConversions, Inc.2023-08-111780
K222128Protective Gown AAMI Level 4Kenpax International Limited2023-08-083860
K212464Dukal Corporation AAMI Level 4 Open-Back Protective GownDukal Corporation2022-03-302360
K203821Donagamex Blue Performance Protective GownDong Nai Garment Corporation (Donagamex)2021-12-173530
K210405ProTEC-USA EZDoff GownCadillac Products, Inc.2021-12-153080
K182830Cardinal HealthTM Poly-Coated Open-Back Protective GownCardinal Health200, LLC2019-04-262030
K160337Safecare Open Back Protective Gowns and ValueCare Open Back Bam Corporation Limited2017-07-075150

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