Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

ECG · Predicate Candidate Screening

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

48 daysmedian FDA review time

87 days90th percentile

7clearances measured

K-number	Device	Applicant	Decided	Review days
K895164	EAGLE DS	American Sterilizer Co.	1989-11-17	87
K843234	CITOMAT AUTOCLAVES	Lic-Orthion	1984-10-25	69
K811237	MAGNETIC RETENTION UNIT	Universiti Malaya	1981-06-16	43
K810977	ENDODONTIC POST SYSTEMS	Preat Corp.	1981-05-13	33
K790290	NEY EQUI-HINGE	Deringer-Ney, Inc.	1979-04-10	61
K790078	BAR & RIDER, SCREWS, TUBES	Eurodent, Inc.	1979-02-27	48
K771266	STEAM STERILIZER	Amsco Hospital Products Co.	1977-08-02	20

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