Atlas FDA

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

Ascep, Inc. — Predicate Candidate Screening

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

36 daysmedian FDA review time
78 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K830219VARIOUS INSTRUMENTS & INSTRUMENT TRAYSAscep, Inc.1983-04-12780
K822893G.E.V. DISPOSABLE SCALPELSAscep, Inc.1982-10-22240
K810004STERILE DISPOSABLE INSTRUMENT TRAYSAscep, Inc.1981-01-26200
K802726INSTRUMENTS NONSTERILE & STERILEAscep, Inc.1980-11-19230
K791886I.V. CARE KITAscep, Inc.1979-10-26450
K791885I.V. START SETAscep, Inc.1979-10-22410
K791887CENTRAL VENOUS CATHETER DRESSING TRAYAscep, Inc.1979-10-17360
K791888CATHETER CARE KIT REORDER 7940&7941Ascep, Inc.1979-10-17360
K791889SUTURE REMOVAL TRAY, REORDER 7950&7951Ascep, Inc.1979-10-17360

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