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

Del Mar Avionics — Predicate Candidate Screening

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

73 daysmedian FDA review time

225 days90th percentile

54clearances measured

K-number	Device	Applicant	Decided	Review days
K990027	OMNICORDER, MODEL 464	Del Mar Avionics	1999-02-09	35
K971696	SENTINEL RECORDER, MODELS 471/472	Del Mar Avionics	1997-12-30	236
K963174	HOLTER DIGICORDER WITH PACER OPTION (MODEL 483)	Del Mar Avionics	1997-03-13	211
K950020	HOLTER PACERCORDER(R)	Del Mar Avionics	1995-08-17	225
K942653	HOLTER SSR DIGICORDER(TM)	Del Mar Avionics	1995-05-10	341
K922221	SPRINT DX, MODEL 5400 EXERCISE STRESS TEST SYSTEM	Del Mar Avionics	1993-04-21	344
K896862	MODEL 263 SPECTRASCAN(TM) HOLTER ANALYSIS SYSTEM	Del Mar Avionics	1990-04-18	133
K895793	MICROPOTENTIAL ANALYZER/SPECTROCARDIOGRAPHY OPTION	Del Mar Avionics	1990-02-13	138
K894543	MODEL 493 SSR-3 THREE CHANNEL SOLID-STATE RECORDER	Del Mar Avionics	1990-02-08	203
K891148	MODEL 152 DELTA HOLTER ECG ANALYSIS SYSTEM	Del Mar Avionics	1989-05-11	69
K884887	MODEL 499 SSR ANALYSIS SYSTEM	Del Mar Avionics	1989-02-06	76
K884330	MODEL 463 ELECTROCARDIORECORDER RECORDER	Del Mar Avionics	1989-01-05	83
K884009	MODEL 459 ELECTROCARDIOCORDER RECORDER	Del Mar Avionics	1988-11-09	49
K874313	MODEL 492 SSR (TM) RECORDER	Del Mar Avionics	1988-02-22	125
K872658	MODEL 980-CARDIOSCOPE AT-3 ELECTROCARDIOGRAPH	Del Mar Avionics	1988-01-06	183
K863387	MULTIPLE	Del Mar Avionics	1987-09-04	366
K863652	MODEL 456 ELECTROCARDIORECORDER RECORDER	Del Mar Avionics	1986-12-10	83
K860470	DEL MAR MODEL 750 INNOVATOR HOLTER MANAGEMENT SYST	Del Mar Avionics	1986-04-30	83
K860471	DEL AMR MODEL 250 CARDIODISPLAY HOLTER SCANNER	Del Mar Avionics	1986-04-30	83
K854269	MODEL 509A PHYSIOCORDER AMBULATORY RECORDER	Del Mar Avionics	1986-04-11	170
K854268	DEL MAR AVIONICS 5509A PHYSIOSCANNER EEG SCANNER	Del Mar Avionics	1986-03-27	155
K844896	DEL MAR AVIONICS 8300 SECTOR IMAGER SYS	Del Mar Avionics	1985-06-10	175
K850044	TREADMILL E-17	Del Mar Avionics	1985-04-04	87
K850043	CARDIOGUARD STRESS TEST MONITOR 4002	Del Mar Avionics	1985-02-08	32
K841654	DEL MAR AVIONICS 509 NEUROCORDER AMBUL	Del Mar Avionics	1984-12-11	232
K841653	DEL MAR AVIONICS 5509 NEURO-SCANNER	Del Mar Avionics	1984-12-03	224
K840622	CARDIO EXPRESS 100 HOLTER SCANNER	Del Mar Avionics	1984-07-02	139
K833661	ELECTROCARDIOCORDER RECORDER 453	Del Mar Avionics	1983-11-28	41
K822815	MODEL 700 GASTROREFLUX MONITOR/AMALYZER	Del Mar Avionics	1982-10-22	32
K822751	DEL MAR AVIONICS MODEL 551 NEUROCORDER	Del Mar Avionics	1982-10-08	25
K822624	O.T.E. BIOMEDICA B.A.S.I.S. MODEL 2381	Del Mar Avionics	1982-10-06	37
K822700	DEL MAR MODEL 5500 EEG SCANNER	Del Mar Avionics	1982-10-04	27
K820653	OTE BIOMEDICA BERG FOURIER ANALYZER	Del Mar Avionics	1982-05-07	59
K820779	OTE BIOMEDICAL #1296 - 16 CHAN. RECORD	Del Mar Avionics	1982-04-26	34
K820604	OTE BIOMEDICA NEUROGRAPH 9	Del Mar Avionics	1982-03-23	18
K820603	OTE BIOMEDICA NEUROGRAPH 14	Del Mar Avionics	1982-03-23	18
K820605	OTE BIOMEDICA NEUROGRAPH 18	Del Mar Avionics	1982-03-23	18
K813222	MODEL 4200 ELLESTAD STRESS TEST ANALYZER	Del Mar Avionics	1981-12-29	50
K811122	DEL MAR AVIONICS MODELS 9400 & 9401	Del Mar Avionics	1981-06-12	49
K801831	EVALUATOR #9500 DYNAMIC ELEC/SCANNER	Del Mar Avionics	1980-09-09	39
K801832	MODEL 9200 VIS-U-SCAN	Del Mar Avionics	1980-08-27	26
K801830	MODEL 9300 ELECTROCARDIOVALIDATOR	Del Mar Avionics	1980-08-27	26
K792078	MODEL 449 ELECTROCARDIOCORDER	Del Mar Avionics	1979-12-27	73
K792074	MODEL 674 PACER ANALYZER	Del Mar Avionics	1979-12-27	73
K792079	MODEL 447 ELECTROCARDIOCORDER	Del Mar Avionics	1979-12-27	73
K792076	MODEL 448 PACERCORDER	Del Mar Avionics	1979-12-27	73
K792077	MODEL 1981 PRESSUROMETER DATA ANALYSIS	Del Mar Avionics	1979-12-04	50
K792075	MODEL 1978 PRESSUROMETER III AMBULATORY	Del Mar Avionics	1979-12-04	50
K792080	MODEL 656 ARRHYTHMIA ANALYZER	Del Mar Avionics	1979-12-04	50
K792071	DCG DATA TERMINAL	Del Mar Avionics	1979-12-04	15

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