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

Dlp, Inc. — Predicate Candidate Screening

56 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

71 daysmedian FDA review time

163 days90th percentile

56clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K973485	CLEARVIEW BLOWER/MISTER	Dlp, Inc.	1997-12-08	84	1
K964445	OCTOPUS TISSUE STABILIZER (28001/28002/28003/28004/28005/280	Dlp, Inc.	1997-01-30	85	0
K953945	RETROGRADE CORONARY SINUS PERFUSION CANNULA WITH ELONGATED &	Dlp, Inc.	1996-03-26	218	8
K950754	MACRO SUCTION TUBE MODEL NO 10061	Dlp, Inc.	1995-04-25	67	0
K934215	CONTAIN-OR	Dlp, Inc.	1994-02-09	163	0
K915268	CATHETER TWO STAGE VENOUS RETURN	Dlp, Inc.	1992-07-27	245	0
K914608	BREAST LES LOCAL WIRE ST. 48219/49220/48119/48120	Dlp, Inc.	1992-01-09	84	0
K913077	LANCASTER COOLING JACKET, CAT. CODE #13500/13501	Dlp, Inc.	1992-01-09	182	0
K913098	APIRATION BIOPSY SYRINGE GUN, CAT. CODE #54501	Dlp, Inc.	1991-11-05	116	0
K912229	IMA ELECTROCAUTERY ELECTRODE CAT. #60002/60003	Dlp, Inc.	1991-09-25	128	0
K904172	ACCUPLACE (TM)	Dlp, Inc.	1990-11-21	71	4
K900994	ANTEGRADE/RETROGRADE Y W/INTEGRAL SELECTOR SWIT.	Dlp, Inc.	1990-08-15	166	1
K901074	CODE #94315 RETROGRADE CORONARY SINUS PERF CANNULA	Dlp, Inc.	1990-07-06	120	0
K900082	MAXX 470 CORE BIOPSY GUN	Dlp, Inc.	1990-06-27	173	0
K897022	PICSO CANNULA, CATALOG CODE 94315	Dlp, Inc.	1990-03-16	87	0
K896019	MODIFIED DISP. CHIBA-TYPE NEEDLE DESIGNATED ASPI.	Dlp, Inc.	1990-01-03	79	0
K893418	MYOCARDIAL PROBE THERMOMETER CODE 64000	Dlp, Inc.	1989-09-05	126	0
K891537	CORE BIOPSY NEEDLE, CATALOG CODE #54006	Dlp, Inc.	1989-04-18	32	0
K890707	PHRENIC NERVE PAD & NERVE PAD W/1/4 PERCARDIAL	Dlp, Inc.	1989-04-10	59	0
K890453	REUSABLE MLYOCARDIAL BIOPSY FORCEPS (BIOPTOMES	Dlp, Inc.	1989-03-31	60	0
K880860	CORONARY OSTIUM OCCLUDER, CATALOG CODE 32015	Dlp, Inc.	1988-05-26	86	0
K880421	DESCENDING ARCH CANNULA	Dlp, Inc.	1988-04-28	87	0
K875353	PERCUTANEOUS ARTERIAL/VENOUS CANNULA PLACEMENT KIT	Dlp, Inc.	1988-03-22	82	1
K871137	MINISTIK MINI PUNCTURE SET CATALOG CODE #57505	Dlp, Inc.	1987-07-16	118	0
K865079	ASPIRATING NEEDLE, CATALOG CODE #12006	Dlp, Inc.	1987-03-03	64	0
K864329	MODELS 54601/54602/54603/54604 NEEDLE & BIOPSY KIT	Dlp, Inc.	1986-12-03	29	0
K860149	VENOUS PERFUSION CANNULA W/CUFF CAT. NO. 94015	Dlp, Inc.	1986-03-31	75	9
K855089	PERCUTANEOUS GUIDEWIRE PLACEMENT SYRINGE 50505	Dlp, Inc.	1986-02-18	60	0
K854487	VENOUS RETURN CANNULA W/CUFF 91039	Dlp, Inc.	1986-02-10	94	1
K855144	TOURIQUET KIT WITH SNARE	Dlp, Inc.	1986-02-05	41	1
K853586	PRESSURE SENSING SYRINGE 65000	Dlp, Inc.	1985-11-14	80	0
K852232	PRESSURE DISPLAY BOX #60000/TUBING SET #61000	Dlp, Inc.	1985-08-09	79	4
K852184	ELECTRO-CAUTERY KNIFE CLEANER 6000 1	Dlp, Inc.	1985-06-04	15	0
K850385	INTRACARDIAC SUMP 12010	Dlp, Inc.	1985-04-29	87	2
K845046	PUL,MONARY ARTERY VENT CATHETER	Dlp, Inc.	1985-04-03	96	0
K845045	VENOUS RETURN CATHETER SS-1	Dlp, Inc.	1985-04-03	96	3
K842375	VENOUS CANNULA W/BENT, TIP WIRE	Dlp, Inc.	1984-08-10	53	5
K841482	PRESSURE CATHETER PLACEMENT SET 50010	Dlp, Inc.	1984-06-11	63	0
K840922	INTRADISCAL THERAPY NEEDLE 18 GAUGE	Dlp, Inc.	1984-04-24	53	0
K840923	ANGIOGRAPHY NEEDLE W/WO CONNECTION	Dlp, Inc.	1984-04-17	46	0
K840002	ARTERIAL CANNULA CURVED BEVELED TIP	Dlp, Inc.	1984-02-13	41	3
K840001	ARTERIAL CANNULA STRAIGHT BEVELED TIP	Dlp, Inc.	1984-02-13	41	1
K834352	ADULT VENT CATHETER	Dlp, Inc.	1984-01-27	45	0
K834039	INFANT VENT CATHETER 12001 W/SIDE VENT	Dlp, Inc.	1984-01-03	41	3
K831591	AORTIC ROOT CANNULA W/INTEGRAL PRESS	Dlp, Inc.	1983-06-30	44	2
K821149	SUBMISSION CORONARY CANNULA	Dlp, Inc.	1982-05-18	25	0
K820446	CATHETER, MULTIPLE LUMEN	Dlp, Inc.	1982-03-11	21	0
K813367	CUATICO MYELOGRAPHY NEEDLES	Dlp, Inc.	1982-01-05	36	0
K813368	DISPOSABLE CHIBA-TYPE NEEDLE	Dlp, Inc.	1982-01-05	36	1
K810820	CARDIOPULMONARY BYPASS	Dlp, Inc.	1981-04-03	10	3

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