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

DTS — Predicate Candidate Screening

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

64 daysmedian FDA review time

423 days90th percentile

9clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K053021	ESTECH CLEARVIEW MV ATRIAL DEPRESSOR	Estech, Inc.	2006-01-26	92	0
K982891	CALIFORNIA MEDICAL LABORATORIES INC. STANDARD AND SMALL RIGI	California Medical Laboratories, Inc.	1998-09-30	44	10
K963756	IBC CARDIAC SUCTION WARD	International Biophysics Corp.	1997-11-14	423	2
K905008	FLEXIBLE INTRACARDIAC SUCTION DEVICE	Gish Biomedical, Inc.	1991-01-23	78	0
K900339	HAND-HELD INTRACARDIAC SUCKERS W/ERGONOMIC HANDLES	Shiley, Inc.	1990-03-28	64	0
K891906	ROBICSEK INTRACARDIAC SUCTION WAND	Gish Biomedical, Inc.	1989-06-13	78	0
K801641	OHIO DISPOSABLE CLEAR SUCTION INSTRUMENT	Ohio Medical Products	1980-07-28	11	0
K801400	DISPOSABLE SUCKER SYSTEM	Texas Medical Products, Inc.	1980-06-30	17	0
K791846	DISPOSSABLE SUCTION TUBE, 6 FRENCH	Dlp, Inc.	1979-10-02	13	0

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