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

Travenol Laboratories, S.A. — Predicate Candidate Screening

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

42 daysmedian FDA review time

120 days90th percentile

206clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K874181	BAXTER BEDSIDE SYSTEM	Travenol Laboratories, S.A.	1988-02-22	131	0
K873894	CONTINU-FLO SOLUTION W/CHECK VALVE 2 Y-INJECT SITE	Travenol Laboratories, S.A.	1987-11-05	42	0
K873873	RESUBMITTED MICRON TRANSFUSION FILTER	Travenol Laboratories, S.A.	1987-10-22	52	0
K873984	AUTOMATIC PERITONEAL DIALYSIS CYCLER SET (5C4437)	Travenol Laboratories, S.A.	1987-10-20	20	0
K872364	HEMODIALYSIS (SPS), MODEL 550, CODE 5M1309	Travenol Laboratories, S.A.	1987-10-13	117	2
K872652	UPGRADED AUTO PERITONEAL DIALYSIS CYCLER SYSTEM	Travenol Laboratories, S.A.	1987-09-30	85	0
K870801	FLO-GARD 6200 VOLUMETRIC INFUSION/PUMPING BLOOD	Travenol Laboratories, S.A.	1987-09-04	189	0
K871908	IV ADMINISTRATION SET	Travenol Laboratories, S.A.	1987-07-27	73	0
K871471	CAPILLARY FLOW DIALYZERS MODELS ST-12 & ST-15	Travenol Laboratories, S.A.	1987-06-12	59	0
K865029	CONTINU-FLO SOLUTION ADMIN. SET W/IN-LINE FILTER	Travenol Laboratories, S.A.	1987-04-17	115	0
K870169	CAPILLARY FLOW DIALYZERS	Travenol Laboratories, S.A.	1987-04-06	82	0
K870940	SOLUTION ADMINI. SETS- ALTER. DRIP CHAMBER/CONNEC.	Travenol Laboratories, S.A.	1987-03-17	8	0
K870145	EXTERNAL Y VALVE 5C4198	Travenol Laboratories, S.A.	1987-03-10	56	0
K863864	AMBULATORY INFUSION PUMP, MODEL AS30C	Travenol Laboratories, S.A.	1987-02-04	124	0
K863468	EXACTECH(TM)	Travenol Laboratories, S.A.	1986-12-08	91	0
K864338	SECONDARY SET LOCK	Travenol Laboratories, S.A.	1986-11-19	15	0
K860353	SYRINGE INFUSION PUMP	Travenol Laboratories, S.A.	1986-09-05	218	0
K861761	ACCESSUS DRY STORAGE PACKAGE STERILE COMP STORAGE	Travenol Laboratories, S.A.	1986-08-28	114	0
K861618	TRAVASORB FEEDING TUBES - (2L8014) AND (2L8024)	Travenol Laboratories, S.A.	1986-07-15	77	0
K861776	HIGH EFFICIENCY HEMODIALYSIS SYSTEM	Travenol Laboratories, S.A.	1986-06-19	42	0
K862152	TISSUE CULTURE FLASK PL 732 PLASTIC ACCESSORY PROD	Travenol Laboratories, S.A.	1986-06-16	13	0
K860362	SILICATH-AG SILICONE ELASTOMER FOLEY CATHETER	Travenol Laboratories, S.A.	1986-04-29	89	0
K860162	FLO-GARD 6200 VOLUMETRIC INFUSION PUMP	Travenol Laboratories, S.A.	1986-04-18	91	0
K860833	EPIDURAL ANESTHESIA TRAY	Travenol Laboratories, S.A.	1986-04-17	43	0
K861253	TISSUE CULTURE FLASK PL 732 PLASTIC	Travenol Laboratories, S.A.	1986-04-11	8	0
K853663	ACCESSUS CRYOPRESERVATION PKG. STERILE TISSUE STOR	Travenol Laboratories, S.A.	1986-04-09	218	0
K860700	CAPD DISCONNECT SYSTEM 5C4182, 5C4183, 5C4186	Travenol Laboratories, S.A.	1986-04-07	41	0
K860746	AUTO SYRINGE MICRO VOL EXT SET W/AIR VENT FILTER	Travenol Laboratories, S.A.	1986-04-07	39	2
K860541	SOLUTION ADMINISTRATION SET	Travenol Laboratories, S.A.	1986-03-25	41	0
K860272	SOLUTION ADMINISTRATION SETS	Travenol Laboratories, S.A.	1986-03-18	50	6
K854168	TRAVENOL DISPOSABLE DENTAL SCALERS/CURETTES	Travenol Laboratories, S.A.	1986-03-13	149	0
K854863	FLO-GARD 4000 VOLUMETRIC INFUSION CONTROLLER	Travenol Laboratories, S.A.	1986-02-12	69	0
K855003	BERAHA BIOPSY NEEDLES, 2N2730, 2N2731 & 2N2732	Travenol Laboratories, S.A.	1986-02-10	59	0
K860230	CAPD TRANSFER SET SPIKE 5C4363	Travenol Laboratories, S.A.	1986-02-05	14	0
K854586	HOLLOW FIBER DIALYZER	Travenol Laboratories, S.A.	1985-12-13	25	0
K853881	THE TRAVENOL 5 ML/HR INFUSOR	Travenol Laboratories, S.A.	1985-12-02	74	0
K854517	NEW TRAVENOL ROLLER CLAMP-SOLUTION ADMIN. SET	Travenol Laboratories, S.A.	1985-12-02	20	0
K853830	SLIDING RECONSTITUTION DEVICE W/ADMIX VIALEX PLAST	Travenol Laboratories, S.A.	1985-11-06	54	0
K842905	TRAVENOL MULTIDAY INFUSOR 2C1080	Travenol Laboratories, S.A.	1985-11-01	465	0
K853550	TRAVENOL CAPD Y SET 5C4354	Travenol Laboratories, S.A.	1985-10-04	39	0
K853208	125I ESTRADIOL DIRECT RADIOIMMUNOASSAY	Travenol Laboratories, S.A.	1985-08-19	19	0
K852678	CAPD TRANSFER SET FOR REDUCED FILL VOLUMES 5C4353	Travenol Laboratories, S.A.	1985-07-29	34	0
K851940	STERILE WATER FOR INHALATION USP 2D0799	Travenol Laboratories, S.A.	1985-06-20	48	0
K851074	VARIABLE NEBULIZER HEATER	Travenol Laboratories, S.A.	1985-06-18	92	0
K850637	EXOTHERMIC HEATING PAD	Travenol Laboratories, S.A.	1985-04-25	65	0
K851208	COMPACT EXCHANGE DEVICE 5C4197	Travenol Laboratories, S.A.	1985-04-08	13	0
K851207	EXTENDED LIFE CAPD SOLUTION TRANSFER SET 5C4153	Travenol Laboratories, S.A.	1985-04-08	13	0
K850710	TRAVENOL FLO-GARD 500 IV MONITOR	Travenol Laboratories, S.A.	1985-04-04	41	0
K850061	MICRO VOLUME DOUBLE LINE EXTENSION SET	Travenol Laboratories, S.A.	1985-03-27	78	0
K850756	AUTO-D AUTOMATIC DISINFECTION ACCESS/ATTACHMENTS	Travenol Laboratories, S.A.	1985-03-20	23	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