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

EWD — Predicate Candidate Screening

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

137 daysmedian FDA review time

317 days90th percentile

14clearances measured

K-number	Device	Applicant	Decided	Review days
K020296	ADULT SILICONE EAR PLUGS, MODELS # 68053, 68057	Apothecary Products, Inc.	2002-06-25	148
K972923	SUPER SILIPLUGS EAR PLUGS	Interview Medical Technology Corp.	1997-10-27	80
K971517	SILICONE PUTTY EAR PLUGS	Bentec Medical, Inc.	1997-06-02	38
K962292	HEARSAVER	Emtech Laboratories	1996-10-29	137
K960500	THE VIRTUAL M-332	Virtual Corp.	1996-04-03	61
K945376	DOC'S PROPLUGS EAR PLUGS	Doc'S Proplugs, Inc.	1995-11-14	389
K930203	MODEL 322 CLINICAL AUDIOMETER	Virtual Corp.	1993-07-08	175
K915739	#903 SILAFLEX II	Flents Products Co., Inc.	1992-06-30	197
K910177	SEAL-RITE SILICONE EAR PLUG	Flents Products Co., Inc.	1991-06-24	160
K862045	DOC'S PROPLUGS EAR PLUGS	Doc'S Proplugs, Inc.	1987-04-10	317
K821187	MEDCO CUSTOM EAR PROTECTOR MOLD KIT	Santa Barbara Medco, Inc.	1982-05-27	30
K791608	BILSOM PROPP	Bilson International, Inc.	1979-10-10	58
K781907	EAR STOPPLES FOR NOISE ATTENTION	Crown Delta Corp.	1978-11-22	8
K781491	PRO-MOLD, CUSTOM EAR	Mcghan Medical Corp.	1978-09-27	30

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