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

Electromedics, Inc. — Predicate Candidate Screening

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

78 daysmedian FDA review time

213 days90th percentile

41clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K934964	ELECTROMEDICS TYMPANIC TEMPERATURE SENSOR	Electromedics, Inc.	1994-03-07	143	0
K933832	ELECTROMEDICS HG (HYDROGEL) SERIES SKIN TEMPERATURE SENSOR	Electromedics, Inc.	1994-01-28	176	0
K934355	ELECTROMEDICS BLOOD HEAT EXCHANGER	Electromedics, Inc.	1993-12-03	87	0
K930154	EL2-SERIES BLOOD COLLECTION REERVOIR	Electromedics, Inc.	1993-07-01	169	1
K926250	ELECTROMEDICS EL-SERIES CARDIOTOMY RESERVOIR	Electromedics, Inc.	1993-02-19	67	0
K925412	ELECTROMEDICS TISSUE TRAP/ #TT280	Electromedics, Inc.	1993-02-05	102	0
K915737	AUTOTRANSFUSION BLOOD COLLECTION RESERVOIR	Electromedics, Inc.	1992-09-03	258	0
K910238	PORTABLE AUTO TRANSFUSION SYSTEM 500	Electromedics, Inc.	1991-06-19	152	0
K910935	MODIFIED PYROGEN TESTING	Electromedics, Inc.	1991-05-16	91	0
K902723	ARTERIAL BLOOD FILTER ELECTRO. AIR* STAR 40 AND 20	Electromedics, Inc.	1990-12-13	177	0
K903392	ELECTROMEDICS BT422-120 AND BT422-40	Electromedics, Inc.	1990-09-06	41	0
K893218	AP900/PRP MODULE AND ACCESSORIES, MODIFICATION	Electromedics, Inc.	1990-06-12	411	0
K900104	TCPM II TOURNIQUET CUFF PRESSURE MONITOR	Electromedics, Inc.	1990-03-15	65	0
K873561	ELECTROMEDICS D1079E	Electromedics, Inc.	1987-11-05	64	0
K871847	BT-795/ATS	Electromedics, Inc.	1987-06-19	38	0
K860306	BT-795/P AUTOMATED AUTOTRANS	Electromedics, Inc.	1986-03-06	37	0
K842391	ACR 2500 CARDIOTOMY RESERVOIR FILTER	Electromedics, Inc.	1985-05-21	337	0
K844803	POLYESTER CARDIOTOMY RESERVOIR, FILTERED & UNFILTE	Electromedics, Inc.	1985-04-29	139	0
K832897	MODEL TTPM TIME TEMP. PRESSURE MONITOR	Electromedics, Inc.	1984-03-22	213	0
K832272	TOURNIQUET CUFF PRESSURE MONITOR #TCPM	Electromedics, Inc.	1983-11-28	139	0
K831458	CARDIOPLEGIA RECIRCULATION SYS-BL 705/A	Electromedics, Inc.	1983-10-20	167	0
K831743	STERILE FOLEY CATHETERS & UROLOGICAL	Electromedics, Inc.	1983-09-12	104	0
K830639	HI FLEX D-700 MODULAR BUBBLE OXYGENA-	Electromedics, Inc.	1983-05-25	85	0
K830592	DISPOS. TYPE T THERMOCOUPLE TEMP.PROBE	Electromedics, Inc.	1983-05-18	83	0
K830735	BT 795/A AUTOTRANS	Electromedics, Inc.	1983-05-02	55	0
K823681	MODEL ICPM & ACCESSORIES	Electromedics, Inc.	1983-02-23	78	0
K823126	MODEL SA-1 STETHOSCOPE AUDIO AMPLIFIER	Electromedics, Inc.	1982-11-16	22	0
K822098	BT 794-BLOOD/FLUID WARMER	Electromedics, Inc.	1982-08-20	35	0
K822097	D645-BACTERIOLOGICAL GAS LINE FILTER	Electromedics, Inc.	1982-07-30	14	0
K813264	D6ZO DISPOSABLE HEAT EXCHANGER	Electromedics, Inc.	1982-07-06	228	0
K813459	REUSABLE & DISPOSABLE TEMP. PROBES	Electromedics, Inc.	1982-03-26	115	0
K812292	AUTOTRANS BT795	Electromedics, Inc.	1981-10-23	71	0
K812455	SUCKER CARDIOTOMY RETURN, C.P. BYPASS	Electromedics, Inc.	1981-10-23	56	0
K812758	PHYSIOLOGICAL PRESSURE TRANSDUCER	Electromedics, Inc.	1981-10-20	19	0
K803277	TYGON TUBING	Electromedics, Inc.	1981-01-13	15	0
K771995	ELECTROTHERM MODELS TC-100 & M-99	Electromedics, Inc.	1977-11-22	32	0
K771996	TELETHERMOMETER MODEL T T-100	Electromedics, Inc.	1977-11-22	32	0
K771999	ELECTROTHERM MODELS F&C18,14,78, F84	Electromedics, Inc.	1977-11-15	25	0
K771998	TEMP-A-LERT MODEL TA-986	Electromedics, Inc.	1977-11-15	25	0
K771997	TELETHERMOMETER MODEL T T-400	Electromedics, Inc.	1977-11-15	25	0
K771994	ELECTROTHERM MODEL HT-1	Electromedics, Inc.	1977-11-02	12	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