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

EPP — Predicate Candidate Screening

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

43 daysmedian FDA review time

87 days90th percentile

15clearances measured

K-number	Device	Applicant	Decided	Review days
K942158	AQUAPLAST NASAL SPLINTS, PRECUT SILVER SPLINT PATTERNS AND S	Wfr/Aquaplast Corp.	1994-07-29	87
K942724	EXTERNAL NASAL SPLINT	Micromed Development Corp.	1994-07-08	29
K895502	MICROTEK REUTER-STYLE BI-VALVE INTRANASAL SPLINT	Microbio-Medics, Inc.	1989-12-08	87
K890599	HOOD NASAL SPLINT	Hood Laboratories	1989-03-17	39
K882244	RICHARDS THERMOPLASTIC DORSAL NASAL SPLINT	Richards Medical Co., Inc.	1988-06-23	23
K872905	AMERICAN NASAL SPONGE	American Silk Sutures, Inc.	1987-09-04	42
K864930	'EXMOOR' ATKINS NASAL SPLINT	Exmoor Plastics , Ltd.	1987-03-04	78
K864933	'EXMOOR' SHAH & MACKAY NASAL SPLINTS	Exmoor Plastics , Ltd.	1987-03-04	78
K864932	'EXMOOR' CAWOOD NASAL SPLINTS	Exmoor Plastics , Ltd.	1987-03-04	78
K864934	'EXMOOR' SHAH SILICONE DISCS	Exmoor Plastics , Ltd.	1987-01-28	43
K863382	CANNON NASAL SPLINT	Treace Medical, Inc.	1986-10-07	34
K862496	MICROTEK INTRANASAL SPLINT	Microtek Medical, Inc.	1986-07-14	13
K810738	GOODE MAGNETIC NASAL SPLINT	Xomed, Inc.	1981-03-31	13
K791681	THE DENVER SPLINT	Xomed, Inc.	1979-10-22	55
K791053	THE DENVER SPLINT	Ronald D. Shippert, M.D.	1979-08-16	71

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