Atlas FDA

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

FBM — Predicate Candidate Screening

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

50 daysmedian FDA review time
263 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K960400DIAMOND-TOUCH AND MICRO DIAMOND-TOUCH INSTRUMENTS/DIAMOND-LISnowden-Pencer1996-03-12430
K932021ENTREE CANNULA FASCIA ANCHORSCore Dynamics, Inc.1994-01-112630
K911813ENTREE CANNULACore Dynamics, Inc.1991-07-19870
K900955GS-4000 REDUCER SLEEVE, 11MM TO 5MMSolos Endoscopy, Inc.1990-04-18500
K900965GS-4550 TROCAR ONLY, 11MMSolos Endoscopy, Inc.1990-04-18500
K900962GS-4300 CANNULA AND TROCAR, 5.5MMSolos Endoscopy, Inc.1990-04-18500
K900961GS-4100 REDUCER SLEEVE, 5MM TO 3MMSolos Endoscopy, Inc.1990-04-18500
K900963GS-4350 TROCAR ONLY, 5.5MMSolos Endoscopy, Inc.1990-04-18500
K900964CANNULA AND TROCAR, 11MMSolos Endoscopy, Inc.1990-04-18500

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