Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

KYX — Predicate Candidate Screening

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

57 daysmedian FDA review time

218 days90th percentile

11clearances measured

K-number	Device	Applicant	Decided	Review days
K143177	KleenGel Dispenser	Kleengel, LLC	2015-09-14	314
K980109	CYCLOTECH CYCLOSPORINE ORAL SOLUTIONS DISPENSER	Sangstat Medical Corp.	1998-08-18	218
K954181	CANYONS BI-DIRECTIONAL CHECK VALVE	Canyon Medical Products	1995-11-29	84
K830571	BOTTLE ADAPTER	Burron Medical Products, Inc.	1983-03-24	29
K801008	MULTI-AD FLUID DISPENSING PUMP MP-3000	Burron Medical Products, Inc.	1980-06-02	35
K800362	FLUID DISPENSING SYSTEM	Pharmaseal Laboratories	1980-03-12	21
K800437	SYRINGE TIP CONNECTOR	Burron Medical Products, Inc.	1980-03-12	14
K792227	MULTI-AD FLUID DISPENSING SYSTEM	National Patent Development Corp.	1979-12-20	45
K781364	PINT BOTTLE WELL	Baxa Corp., Sub. of Cook Group, Inc.	1978-10-17	71
K771539	STEPPER	Tridak	1977-10-07	57
K760517	CUP, DISPOSABLE MEDICINE	Landmark Plastics	1976-11-12	79

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