Atlas FDA

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

Perlink USA, Inc. — Predicate Candidate Screening

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

160 daysmedian FDA review time
388 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K922358STERLING POWDER FREE PATIENT EXAMINATION GLOVESPerlink USA, Inc.1993-06-113880
K924959STERLING LATEX EXAM GLOVE, HYPO-ALLERGENICPerlink USA, Inc.1993-03-031540
K921438DISPOSABLE LATEX EXAMINATION GLOVESPerlink USA, Inc.1992-06-23900
K896707PERLINK SCREEN, KIRAN SCREENPerlink USA, Inc.1990-08-302750
K901790THERMOMETER, MERCURY/CLINICALPerlink USA, Inc.1990-07-11830
K896708PERLINK CASSETTE, KIRAN CASSETTEPerlink USA, Inc.1990-05-071600

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