Atlas FDA

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

MCZ — Predicate Candidate Screening

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

121 daysmedian FDA review time
256 days90th percentile
15clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K050656AMSINO SUTURE REMOVAL KITAmsino International, Inc.2005-05-02490
K964827PROD. NO. 01-132 - SUTURE REMOVAL KITContinental Medical Laboratories, Inc.1997-02-14740
K963714GRAND MEDICAL SUTURE REMOVAL KITGrand Medical Products1996-11-27720
K943046SKIN STAPLE REMOVAL TRAYSSterile Concepts, Inc.1994-07-29320
K941465SUTURE REMOVAL KITClinical Resources, Inc.1994-04-22250
K931597CARAPACE INCISION AND DRAINAGE TRAYSCarapace, Inc.1993-11-052180
K925015STERILE SUTURE REMOVAL KITCustomed, Inc.1993-06-072562
K924834PREMIERE STERILE SUTURE REMOVAL KIT(HC-50-54957)American Healthcare Supply Co., Inc.1993-03-231790
K924835VALU-PAK STERILE SUTURE REMOVAL KIT (AHC-50-549560American Healthcare Supply Co., Inc.1993-03-231790
K922339SUTURE REMOVAL KITTransidyne General Corp.1992-12-112060
K915827A.C.S. SUTURE REMOVAL KITAmerican Carolina Stamping1992-12-083440
K920283DISPOSABLE SKIN STAPLE REMOVERTrinity Laboratories, Inc.1992-05-221210
K920280SUTURE REMOVAL KIT, STERILE, DISPOSABLETrinity Laboratories, Inc.1992-05-111100
K910361SUTURE REMOVAL KITMegadyne Medical Products, Inc.1991-03-27570
K812132STERILE SUTURE REMOVAL KITE.M. Adams1981-12-011260

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