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

Orthoconcept, Inc. — Predicate Candidate Screening

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

71 daysmedian FDA review time
492 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K925160ARTHRO FMS 4Orthoconcept, Inc.1994-02-174920
K910164ORTHOCONCEPT ARTHROSCOPIC PUMPOrthoconcept, Inc.1991-03-27710
K905785ARTHRO-FMS-3/IRRIGATION SETS (VARIOUS)Orthoconcept, Inc.1991-03-26970
K896196ARTHROSCOPY DISP. & REUSABLE SHAVER BLADES, RECHAROrthoconcept, Inc.1989-12-01370
K895643MODIFIED UROPUMP* FLUID MANAGEMENT SYSTEMOrthoconcept, Inc.1989-10-17500
K894363UROPUMP* FLUID MANAGEMENT SYSTEMOrthoconcept, Inc.1989-08-11280
K882469CORDEX SHAVER, BLADES, RECHARGER AND BATTERIESOrthoconcept, Inc.1988-12-011690
K872270ORTHOCONCEPT ARTHROSCOPIC PUMP ORTHOPUMPOrthoconcept, Inc.1987-07-21390

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