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

ECB — Predicate Candidate Screening

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

89 daysmedian FDA review time

269 days90th percentile

12clearances measured

K-number	Device	Applicant	Decided	Review days
K942519	UNI-SYRINGE, UNI-TIP AND ACCESS SYRINGE TIPS	Bull Frog Mfg. Co.	1994-08-23	89
K931772	SURETIP SYRINGE TIP COVER	Western M/D, Inc.	1994-03-07	332
K931137	DENTAL SYRINGE TIP	A-Dec, Inc.	1993-11-29	269
K923876	RISKONTROL SINGLE USE	Riskontrol	1993-04-05	245
K923285	PRO-TIP DISPOSABLE 3/1 SYRINGE NOZZLE	Smith & Nephew, Inc.	1992-09-15	71
K920499	SANI-TIP	Dw Industries, Inc.	1992-05-03	90
K911756	POSTERIOR NASAL EPISTAXIS INSTRUMENTS	Richard Wolf Medical Instruments Corp.	1991-10-24	189
K890290	BRACE (ORAFIX SPECIAL)	Norcliff Thayer, Inc.	1989-03-29	69
K863024	SERINGA TRIPLICE S.L.	Sds Dental, Inc.	1986-09-25	48
K854699	TUBING SYRING	Almore Intl., Inc.	1986-01-06	46
K801686	SPACELINE THREE WAY SYRINGE	Pacific Dental Corp.	1980-08-04	14
K781594	DENTAL WARM WATER IRRIGATING SYSTEM	Rama Corp.	1978-12-04	80

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