Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

1978 — Predicate Candidate Screening

1,975 FDA 510(k) clearances under this clearance year; the 50 most recent screened below.

32 daysmedian FDA review time

84 days90th percentile

1,975clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K781944	STOCKINETTE	Kimberly-Clark Corp.	1978-12-29	38	0
K781794	BETA-TEC	Wampole Laboratories	1978-12-29	65	0
K782108	MEDTRONIC MODEL 546	Medtronic Vascular	1978-12-29	10	0
K781878	LIGHT, INSIDE	Midwest	1978-12-29	53	0
K782076	HT-110 MICROMINI	Health Tech	1978-12-29	16	0
K782065	LASER, PHOTOCOAGULATION	Cavitron Corp.	1978-12-28	15	0
K781788	GOLD, 24 KARAT CASTING	Williams Gold Refining Co., Inc.	1978-12-28	70	0
K781882	MODULAT DENTAL SYSTEMS	Vacudent Sales Corp.	1978-12-28	65	0
K781974	IMPLANT DRIVERS AND TIPS	Miter, Inc.	1978-12-28	31	0
K782064	TABLE, EXAMINING-TWO EIGHTY	Amsco Co.	1978-12-28	15	0
K782120	SPONGE SYSTEM, ROSERING CONTAIN-COUNT	Medline Industries, Inc.	1978-12-27	0	0
K782146	PACEMAKER, MODEL DDP ELECTRONIC CIRCUIT	Arco Medical Products Co.	1978-12-27	0	0
K782152	VALVE, AMBU PEEP	Narco Air-Shields	1978-12-26	0	1
K781910	MONITOR, SENSOMATIII OXYGEN	Biochem International, Inc.	1978-12-26	42	0
K782022	MICROLITH A MODEL 703	Cardiac Pacemakers, Inc.	1978-12-22	17	0
K782097	ELECTRODE LEAD MODEL 030-198	Telectronics, Inc.	1978-12-22	4	0
K782029	MAXI CAMERA 400T	General Electric Co.	1978-12-22	17	0
K780430	LITHICRON F PROGRAMMABLE PULSE GEN	Medcor, Inc.	1978-12-22	280	0
K782023	MICROLITH A MODEL 803	Cardiac Pacemakers, Inc.	1978-12-22	17	0
K782059	TRANSMITTER, TR-1 ECG	Burdick Corp.	1978-12-21	14	0
K781926	VENTILATOR, INFANT MODEL 100	Healthdyne, Inc.	1978-12-21	43	0
K781624	PACING LEAD MODEL BUS 860, BUS 890	R.E. Brown Co., Inc.	1978-12-21	92	0
K781835	PULSTRON MODEL 100	Micro-Rel	1978-12-21	52	0
K782074	VENTILATOR, MODEL AVA-1, ADULT	Rule Medical Instruments, Inc.	1978-12-21	8	0
K780527	CORTRAL I	Hospal Medical Corp.	1978-12-20	261	0
K781900	ANALYZER, AUTOMED CENTRIFUGAL	Autogenic Systems	1978-12-20	37	0
K781688	LINER, CAVITY CALCIUM HYDROXIDE	Kerr Corporation (Danbury)	1978-12-20	77	0
K781893	CONTROL, PROTEIN ELECTROPHORESIS	Sigma Chemical Co.	1978-12-20	42	0
K781728	EXTUBE	Analytichem International, Inc.	1978-12-20	75	0
K781898	CLEARING SOLUTION #ECA01976	Electrophoresis Corp. of America	1978-12-20	37	0
K781862	BLOOD GROUP SUBSTANCE A	North American Biologicals, Inc.	1978-12-20	44	0
K781771	DETECTOR, MODEL 79875A, VARIABLE	Hewlett-Packard Co.	1978-12-20	68	0
K782090	CLAMP, DISPOSABLE	Concord Laboratories, Inc.	1978-12-20	6	0
K781802	WASHER SYSTEM, MICROELISA	Metrix Teknika, Inc.	1978-12-20	58	0
K781567	API ZYM	Analytical Products, Inc.	1978-12-20	97	0
K781638	RUBINDEX*DIRECT SYSTEM	Ortho Diagnostics, Inc.	1978-12-20	90	0
K781979	SURGAIRTOME TWO	American Sterilizer Co.	1978-12-20	23	2
K782027	HYSTERECTOMY T DRAIN	Davol, Inc.	1978-12-20	15	0
K782047	PROCESSING SYSTEM, A2 IMAGE	Medtronic Vascular	1978-12-20	12	0
K781632	UROTRON	Boehringer Mannheim Corp.	1978-12-20	86	0
K781884	SERUM, CREATININE DETERMINATIONS	Fisher Scientific Co., LLC	1978-12-20	43	0
K781885	SERUM, BLOOD UREA NITIOGEN	Fisher Scientific Co., LLC	1978-12-20	43	0
K781464	HEMODIALYZER, MODEL RP610, RP AN 69	Hospal Medical Corp.	1978-12-20	117	0
K781948	COLUMN TEST, HEMOGLOBIN A	Bio-Rad	1978-12-20	29	0
K781762	COMPRESSION HIP SCREW SYSTEM	Howmedica Corp.	1978-12-20	65	0
K781875	STAIN KIT FOR CELL CULTURES (30-100-00)	Flow Laboratories, Inc.	1978-12-20	47	0
K781874	MYCOPLASMA ARGININI FITC (30-403-41)	Flow Laboratories, Inc.	1978-12-20	47	0
K782082	CATHETER, DIGITAL POSITRAL II	C.R. Bard, Inc.	1978-12-20	6	0
K781962	DIJI-DENT	J&J Technologies, Inc.	1978-12-20	29	0
K782005	RADIATION ONCOLOGY SYSTEM	Adac Laboratories	1978-12-20	16	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