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

EPY — Predicate Candidate Screening

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

28 daysmedian FDA review time

113 days90th percentile

12clearances measured

K-number	Device	Applicant	Decided	Review days
K950086	PEDIA PALS, INCORPORATED	Pedia Pals, Inc.	1995-02-07	28
K925754	ECONOM	Rudolf Riester GmbH & Co. KG	1993-10-08	329
K853588	FIBRELIGHT NASAL SPECULA	Downs Surgical , Ltd.	1985-12-18	113
K834189	JAKOBI SURG. INSTRUMENTS #7 44/47	Imm Enterprises , Ltd.	1984-03-06	106
K822370	UNIVERSAL SPECULUM HOLDER	Treace Medical, Inc.	1982-09-09	34
K822373	EAR SURGERY SPECULUM	Treace Medical, Inc.	1982-09-09	34
K822164	EAR SPECULI	Kelleher Corp.	1982-08-11	19
K791123	EAR AND NOSE SPECULA	Xomed, Inc.	1979-07-10	25
K780723	OTOSCOPE SPECULA	Abco Dealers, Inc.	1978-05-09	7
K772385	THIN-BLADED NASAL SPECULUM	Edward Weck, Inc.	1978-01-17	21
K772370	BARRAQUER OVAL SPECULUM-VARIOUS SIZES	Edward Weck, Inc.	1978-01-17	21
K772380	FARRIOR OVAL SPECULUM	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