Atlas FDA

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

Lca, Inc. — Predicate Candidate Screening

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

151 daysmedian FDA review time
247 days90th percentile
12clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K952792PADLESS ELECTROSURGICAL PENCILLca, Inc.1995-08-28700
K944091THE HOOK-CURVED CLOSED END/ELECT FIBER LASER DELIV SYSLca, Inc.1994-10-07460
K935439SNJ SMOKE EVACUATION SUCTION WANDLca, Inc.1994-03-071150
K935258HYBRID SURGICAL DEVICE MODIFICATIONLca, Inc.1994-01-13730
K925726ALLOY SCALPEL HANDPIECES, MODIFICATIONLca, Inc.1993-11-223740
K931070CLOSED END FIBEROPTIC LASER DELIVERY SYSTEMLca, Inc.1993-10-052170
K924160HYBRID SURGICAL DEVICELca, Inc.1993-04-232470
K923991ZOE LASER, CONTACT ND:YAG LASER SYSTEMLca, Inc.1993-03-312330
K924120MOLDED FIBER CAP DELIVERY SYSTEMLca, Inc.1993-03-192170
K901365LASER FORCEPS HANDPIECELca, Inc.1990-08-211510
K902562REVISED LABELING FOR MODEL CL-0PE ND:YAG LASERLca, Inc.1990-06-2090
K900128CL-OPE CONTACT LASER SYSTEMLca, Inc.1990-04-16970

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