Atlas FDA

Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

KIH — Predicate Candidate Screening

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

34 daysmedian FDA review time
65 days90th percentile
11clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K042591SMARTMIX PRE-FILLED MIXING SYSTEMDePuy Orthopaedics, Inc.2004-10-22290
K943906P.F.C. CEMENT PRESSURIZING SYSTEMJohnson & Johnson Professionals, Inc.1994-12-211320
K897134CMW CEMENT PRESSURISATION SYSTEMDentsply Intl.1990-03-02650
K851881ORTHOPEADIC CEMENT DELIVERY SYSTEMDentsply Intl.1985-06-13450
K840046PRESSURIZING/SCAVENGING ACRYLIC CEMENTPrecision Medical Devices, Inc.1984-02-09340
K833675BRIGHAM TIBIAL CEMENT PRESSURIZERHowmedica Corp.1983-12-12550
K811317HOWMEDICA FEMORAL PRESSURING SEALHowmedica Corp.1981-05-29170
K801388OH-HARRISJohnson & Johnson Professionals, Inc.1980-07-28450
K790275GUN, EXETER CEMENTHowmedica Corp.1979-02-21120
K781955GUN, CEMENTDepuy, Inc.1978-12-04130
K780266BONE CEMENT APPLICATORZimmer, Inc.1978-02-28110

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