Atlas FDA

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

Mectra Labs, Inc. — Predicate Candidate Screening

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

139 daysmedian FDA review time
315 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K113080TUBALGATORMectra Labs, Inc.2012-06-292550
K033880ELECTRO-LUBEMectra Labs, Inc.2004-03-10860
K021247PNEUMOPERITONEUM INSUFFLATION NEEDLEMectra Labs, Inc.2002-11-082030
K993604ENDOSCOPIC ANTI FOG DEVICEMectra Labs, Inc.2000-03-031300
K955352SUCTION CAUTERY PROBEMectra Labs, Inc.1996-04-051360
K934547MECTRA TROCARMectra Labs, Inc.1994-02-181490
K935382GRASPERSMectra Labs, Inc.1994-02-15990
K925691INSUFFLATION TUBINGMectra Labs, Inc.1993-09-233150
K920959INSUFFLATOR, LAPAROSCOPICMectra Labs, Inc.1992-07-131390

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