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

JYO — Predicate Candidate Screening

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

82 daysmedian FDA review time

177 days90th percentile

7clearances measured

K-number	Device	Applicant	Decided	Review days
K910212	COLOR DOPPLER OPTION TO AI 5200 DIAG ULTRASO SYST	Acoustic Imaging Technologies Corp.	1991-07-11	177
K841006	EAR KNIFE-VARIOUS	Premier Dental Products Co.	1984-05-30	82
K840764	EAR KNIVES	Sharpoint, Inc.	1984-05-21	88
K833602	ROLLER KNIFE-TRANSVERSE -SAGITTAL	Microtek Medical, Inc.	1984-01-03	83
K823911	KNIFE BLADE TIP	Treace Medical, Inc.	1983-01-21	24
K772384	MYRINGOTOMY KNIFE	Edward Weck, Inc.	1978-01-17	21
K772372	ROLLER KNIFE	Edward Weck, Inc.	1978-01-17	21

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