Atlas FDA

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

Bio-Interfaces, Inc. — Predicate Candidate Screening

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

195 daysmedian FDA review time
334 days90th percentile
17clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K960164BIO-INTERFACES, INC., BIORESORBABLE CALCIUM PHOSPHATE PARTICBio-Interfaces, Inc.1996-04-10850
K954763BIO-INTERFACES, INC,. BII-PLASTBio-Interfaces, Inc.1996-01-04790
K950598BIORESORBABLE CALCIUM PHOSPHATE PARTICLES - BLL-GRAFTBio-Interfaces, Inc.1995-08-231950
K950567BIO-APATITE 6140 HA PARTICLESBio-Interfaces, Inc.1995-05-09900
K950511BLL-FIL 6140 PARTICLESBio-Interfaces, Inc.1995-04-27800
K933688BII-POREBio-Interfaces, Inc.1994-07-193550
K934049BII-PORE(TM) CANAL WALL PROSTHESISBio-Interfaces, Inc.1994-07-193340
K941431BONE GRAFT DELIVERY SYRINGESBio-Interfaces, Inc.1994-07-121100
K934430BON APATITE HA PARTICLESBio-Interfaces, Inc.1994-05-182470
K934947BII-PLASTBio-Interfaces, Inc.1994-01-261000
K924287710 POROUS HA PARTICLES-BII-POREBio-Interfaces, Inc.1993-04-302480
K924288B1018 POROUS HA BII-POREBio-Interfaces, Inc.1993-04-142320
K9242864060 POROUS HA PARTICULES BII POREBio-Interfaces, Inc.1993-04-142320
K922487BIO-INTERFACES 1840 POROUS HA PARTICLES-BII-POREBio-Interfaces, Inc.1993-04-143220
K9217761840 HA PARTICLESBio-Interfaces, Inc.1992-12-042350
K884732SUPERIOR ENDOSSEOUS DENTAL IMPLANT SYSTEMBio-Interfaces, Inc.1989-05-181890
K8850674060 HA PARTICLESBio-Interfaces, Inc.1989-01-11360

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