Atlas FDA

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

Advanced Biosearch Assn. — Predicate Candidate Screening

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

88 daysmedian FDA review time
106 days90th percentile
22clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K905514AUTOGENESIS(TM) AUTOMATORAdvanced Biosearch Assn.1991-04-021160
K883888CATHSCANNER INTRAVASCULAR ULTRASONIC IMAGING SYST.Advanced Biosearch Assn.1988-12-12880
K854770MARTIN LAMINAR OSTEOSYNTHESIS SYSTEMAdvanced Biosearch Assn.1986-02-11760
K855030CHAMPY BONE PLATES & BONE SCREWSAdvanced Biosearch Assn.1986-01-30450
K855031MANUAL SURGICAL INSTRUMENTS & ACCESS.CHAMPY BONE PAdvanced Biosearch Assn.1986-01-21360
K853916P.M. HIP-FEMORAL PROSTHESISAdvanced Biosearch Assn.1985-12-27950
K852839FREEMAN HIPAdvanced Biosearch Assn.1985-10-291160
K853418SAFTI-BRACELETAdvanced Biosearch Assn.1985-09-20370
K852517CLS HIP PROSTHESISAdvanced Biosearch Assn.1985-09-18970
K852699FREEMAN ACETABULAR CUPAdvanced Biosearch Assn.1985-09-05710
K850773PM CEMENTLESS SCREW-IN ACETABULAR CUPAdvanced Biosearch Assn.1985-05-02660
K844943WEILL CEMENTLESS THREADED ACETABULAR CUPAdvanced Biosearch Assn.1985-03-18880
K844482MULLER TITANIUM BACKED ACETABULAR CUP COMPONENTAdvanced Biosearch Assn.1985-02-19920
K840150TOTAL HIP FEMORAL COMPONENTAdvanced Biosearch Assn.1984-02-27450
K833652YASARGIL FENESTRATED ANEURYSM CLIP &Advanced Biosearch Assn.1984-01-271000
K833650YASARGIL STANDARD ANEURYSM CLIP &Advanced Biosearch Assn.1984-01-18910
K833717PADGETT SUCTION CANNULAAdvanced Biosearch Assn.1983-12-14540
K833651CLIP APPLYING FORCEPSAdvanced Biosearch Assn.1983-11-29410
K832100PSI SURGICAL ASPIRATORAdvanced Biosearch Assn.1983-10-04970
K832302MARK I TOTAL KNEE SYS. ARTHROPLASTYAdvanced Biosearch Assn.1983-08-16330
K830726MARK I & II TOTAL KNEE REPLACE. SYSAdvanced Biosearch Assn.1983-06-221060
K830662NATURAL LOCK ACETABULAR COMPONENTAdvanced Biosearch Assn.1983-04-11390

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