Atlas FDA

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

Conceptus, Inc. — Predicate Candidate Screening

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

214 daysmedian FDA review time
658 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K974028STARGATE FALLOPOSCOPY CATHETER, TRIFURCATED IRRIGATION TUBINConceptus, Inc.1998-01-21900
K972210RESECTOSCOPE SAFETY SHEATHConceptus, Inc.1997-09-05860
K962587CONCEPTUS FALLOPIAN TUBE CATHETEIZATION WITH MICROENDOSCOPY Conceptus, Inc.1997-01-312140
K954164HYSTEROSCOPEConceptus, Inc.1996-03-121890
K953314CONCEPTUS FALLOPIAN TUBE CATHETERIZATION SYSTEMConceptus, Inc.1995-07-28160
K932387CONCEPTUS VARI-SOFT CATH/PIROUETTE POSIT MANDRELConceptus, Inc.1995-03-066580
K932993INTRAUTERINE CATHETER AND INTRODUCERConceptus, Inc.1995-01-065670
K933723CONCEPTUS UTERINE CATHETERConceptus, Inc.1994-12-275120
K933981CERVICAL CATHETERConceptus, Inc.1994-12-274980

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