Atlas FDA

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

Katalyst Surgical, LLC — Predicate Candidate Screening

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

215 daysmedian FDA review time
326 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K213610Kogent Disposable Copper Forceps, Kogent Disposable IrrigatiKatalyst Surgical, LLC2022-10-073260
K192963Kogent Torus Ultrasonic AspiratorKatalyst Surgical, LLC2020-06-192400
K163632Katalyst Cyclophotocoagulation ProbeKatalyst Surgical, LLC2017-06-151750
K141781KOGENT SPETZLER LIGHTED SUCTION TUBESKatalyst Surgical, LLC2015-04-092810
K140362KATALYST REVOLVER LASER PROBES, KATALYST REVOLVER ILLUMINATEKatalyst Surgical, LLC2014-09-152150
K123172KOGENT BIPOLAR FORCEPSKatalyst Surgical, LLC2012-12-21730
K121187KATALYST LASER PROBES, KATALYST ILLUMINATED LASER PROBESKatalyst Surgical, LLC2012-09-171510

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