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

DSF — Predicate Candidate Screening

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

50 daysmedian FDA review time

176 days90th percentile

87clearances measured

K-number	Device	Applicant	Decided	Review days
K910871	EDENTEC DIGITAL CHARTER MODEL 3710	Edentec Corp.	1991-08-29	181
K912929	DASH IV	Astro-Med, Inc.	1991-08-13	39
K905856	MODEL 556 MONITOR	Ge Medical Systems Information Technologies	1991-01-11	88
K902586	GRI LASERGRAPH(TM) ECG PAPER	Gri Medical Products, Inc.	1990-06-22	10
K902230	COLORADO COLOR IMAGING RECORDER	Honeywell, Inc.	1990-06-19	33
K901385	GABRIEL MEDICAL CLS THERMAL RECORDER	Gabriel Medical, Inc.	1990-05-09	44
K895111	TYPE 9541 RECORDER, PAPER CHART	S & W Medico Teknik	1990-01-26	176
K894922	WR3500 AND WR3600 SERIES RECORDERS	Western Graphtec	1990-01-26	177
K894736	MT96000 PAPER CHART RECORDER	Astro-Med, Inc.	1989-12-13	139
K894607	PAQ10 PAPER CHART RECORDER	Protocol Systems, Inc.	1989-10-26	98
K893561	EDENTRACE 670 SYSTEM MULTICHANNEL RECORDER W/OXIM.	Edentec Corp.	1989-08-25	108
K885058	CARDIOCAP(TM) DR-104 REPORTER	Datex Division Instrumentarium Corp.	1989-07-14	219
K890711	DUAL GRAPH (TM) RECORDER-MONITOR	Somatics, Inc.	1989-06-02	109
K884897	FOUR-CHANNEL/EIGHT-CHANNEL THERMAL ARRAY RECORDER	Mennen Medical, Inc.	1989-03-09	106
K890142	A10 ULTRASCOPE RECORDER	Ems Medical, Inc.	1989-02-06	24
K884911	CORTRONIC SCR1000	Cortronic Corp.	1989-01-13	49
K884388	EDENTEC MODEL 4700 SCANNER	Edentec Corp.	1989-01-10	84
K883315	EDENTRACE MULTI-CHARTER MODEL 3700	Edentec Corp.	1988-12-28	145
K881831	WS 800R THERMAL ARRAY RECORDER	Nihon Kohden America, Inc.	1988-07-14	76
K881346	LIFESTAT 1600 PRINTER	Physio-Control Corp.	1988-06-09	71
K880781	DATALOGGER CHART RECORDER	Air-Shields, Inc.	1988-05-11	75
K880554	VSM(R) R2 PAPER CHART RECORDER	Physio-Control Corp.	1988-05-06	87
K872822	MODEL 78576A PAPER CHART RECORDER	Hewlett-Packard Co.	1987-11-04	110
K870538	MODEL 192 PRINTER	Advanced Medical Products, Inc.	1987-04-23	73
K870119	FIBRE OPTIC STRIP CHART RECORDER	Apex Imaging Corp.	1987-04-10	88
K870039	IMAGENET DIGITAL OPHTHALMIC IMAGING SYSTEM	Par Microsystems Corp.	1987-02-12	38
K863331	SIREDOC 60 AND SIREDOC 220	Siemens Medical Solutions USA, Inc.	1986-10-06	40
K862596	DR-2C (MODIFICATION)	General Devices	1986-09-26	91
K855045	MODEL 535 NEO-TRAK RECORDER	Ge Medical Systems Information Technologies	1986-05-16	150
K854866	LONG TERM RECORDER RAG 1200	Nihon Kohden America, Inc.	1986-04-09	152
K851625	SCX-10 SINGLE CHANNEL RECORDER ACCESS. FOR G-2000	Eaton Medical Group	1985-11-19	215
K852487	FUKUDA DENSHI MODEL AU-5001-5003 THERMAL	Fukuda Denshi USA, Inc.	1985-09-19	100
K851626	SCX-35 THREE CHANNEL ACCESS. FOR MODULE G-2000 ELE	Eaton Medical Group	1985-06-26	69
K851274	OHMEDA MODEL 0001/0003 RECORDER	Ohmeda Medical	1985-05-15	44
K850365	RECORDING ACCESSORY FOR G-2000 EKG MACH. GMP-40 RE	Eaton Medical Group	1985-04-09	69
K850487	NOVAMETRIX 350 RECORDER-PAPER CHART RECORDER	Novametrix Medical Systems, Inc.	1985-03-29	50
K850146	SIREDOC, PAPER CHART RECORDER	Siemens Medical Solutions USA, Inc.	1985-02-12	29
K843836	THERMAL GRAYSCALE RF-100	Fukuda Denshi USA, Inc.	1984-10-19	18
K833000	I-CHANNEL RECORDER	Litton Medical Electronics	1984-06-01	288
K832998	2-CHANNEL RECORDER	Litton Medical Electronics	1984-06-01	288
K833656	NARCOTRACE 40 - NT40	Narco Bio-Systems	1984-05-09	202
K832754	MONITORING SYSTEM AS100-AS115 RECORD	Air-Shields, Inc.	1983-12-22	128
K831134	PHOENIX 60/60 PROCESSOR MODULE	Phoenix Corp.	1983-11-07	214
K832012	MEDICAL ELECTRONICS-PRINTER CLOCK	Litton Medical Electronics	1983-10-31	130
K830321	VENTURE II MONITORING SYSTEM	Rae Medical Corp.	1983-06-03	123
K830315	DUAL CHANNEL RECORDER #78574A	Hewlett-Packard Co.	1983-03-31	59
K822978	MINGOGRAF 4, MINGO CARD 4 & MINOCARD 3	Siemens Corp.	1982-12-15	68
K822983	MINGOCARD 7 & MINGOPHONE 7	Siemens Corp.	1982-11-24	47
K823210	MODEL 525 NEO-TRAK NEONATAL RECORDER	Ge Medical Systems Information Technologies	1982-11-24	27
K822432	CENTURION CHART RECORDER	Clinical Data, Inc.	1982-11-01	81

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