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

Laparomed Corp. — Predicate Candidate Screening

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

116 daysmedian FDA review time

175 days90th percentile

10clearances measured

K-number	Device	Applicant	Decided	Review days
K934527	FASCIA STITCHER	Laparomed Corp.	1994-02-25	158
K930569	LAPAROMED LAPAROSCOPIC RETRACTOR SYSTEM	Laparomed Corp.	1993-04-20	89
K921921	CATHETER CHOLANGIOGRAPHY	Laparomed Corp.	1992-08-17	116
K921053	LAPAROMED LIGATING LOOP	Laparomed Corp.	1992-08-06	154
K921006	LAPAROSCOPIC RETRACTOR SYSTEM	Laparomed Corp.	1992-07-28	147
K914066	ELECTROSURGICAL CUTTING/COAGULATION DEVICE/ACCESS	Laparomed Corp.	1991-11-07	57
K910074	LAPAROMED HOOK/SPATULA DEVICE	Laparomed Corp.	1991-07-02	175
K910219	LAPAROMED CHOLANGIOGRAM DEVICE	Laparomed Corp.	1991-04-08	81
K910218	LAPAROMED CHOLANGIOGRAM VACUUM DEVICE	Laparomed Corp.	1991-04-08	81
K905722	SUTURE APPLIER DEVICE	Laparomed Corp.	1991-03-14	84

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