Atlas FDA

Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Louisville Laboratories, Inc. · Predicate Candidate Screening

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

89 daysmedian FDA review time
209 days90th percentile
12clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K980123CARTER-THOMASON NEEDLE-POINT SUTURE PASSER INSTRUMENT SETLouisville Laboratories, Inc.1998-03-09541
K971796LAPAROTOMY BLADDER NECK SUSPENSION KIT WITH BONE ANCHORSLouisville Laboratories, Inc.1997-08-12890
K971791VAGINAL SUTURING KIT FOR LAPAROTOMY BLADDER NECK SUSPENSIONLouisville Laboratories, Inc.1997-07-30760
K971802VAGINAL SUTURING KIT FOR BLADDER NECK SUSPENSIONLouisville Laboratories, Inc.1997-07-30760
K971797LAPAROSCOPIC BLADDER NECK SUSPENSION KITLouisville Laboratories, Inc.1997-07-22680
K971801LAPAROTOMY BLADDER NECK SUSPENSION KITLouisville Laboratories, Inc.1997-07-22680
K963076LAPAROSCOPIC BONE ANCHORED URETHROPEXY INSTRUMENT TRAYLouisville Laboratories, Inc.1997-04-042400
K960882CONTROL SYRINGELouisville Laboratories, Inc.1996-07-081390
K955535LOUISVILLE LABS OXYGEN HEAD TENTLouisville Laboratories, Inc.1996-07-012090
K946282UNIVERSAL URETHRAL CATHETERLouisville Laboratories, Inc.1995-03-31940
K932979EXTERNAL STABILITY PADLouisville Laboratories, Inc.1993-11-021380
K894757T-SCOPE, TELEMETRIC PRECORDIAL STETHOSCOPELouisville Laboratories, Inc.1989-09-18530

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