Medical device manufacturer

Travenol Laboratories, S.A.

Travenol Laboratories, S.A. holds 206 FDA 510(k) clearances across 77 product codes. Median elapsed review time is 41 days. openFDA lists no recall records naming the company.

Updated 11 August 2026 · ingest status · JSON

510(k) clearances: 206
Product codes: 77
Median review: 41 days
Recall records: 0

How does FDA spell Travenol Laboratories, S.A.?

FDA publishes this company under a single spelling, so nothing needed merging here. Many manufacturers are not so tidy.

Which product codes does Travenol Laboratories, S.A. file in?

77 product codes, ranked by how much they file in each.

Product codes this company holds clearances in, with their median elapsed review time in each.
Code	Device	Clearances	Median review	Latest
FRN	Pump, Infusion	23	73 days	22 February 1988
FPA	Set, Administration, Intravascular	21	43 days	5 November 1987
KDJ	Set, Administration, For Peritoneal Dialysis, Disposable	12	39 days	20 October 1987
BTT	Humidifier, Respiratory Gas, (Direct Patient Interface)	9	21 days	20 June 1985
CAF	Nebulizer (Direct Patient Interface)	8	28 days	18 June 1985
FKX	System, Peritoneal, Automatic Delivery	8	33 days	30 September 1987
KOC	Accessories, Blood Circuit, Hemodialysis	8	23 days	18 October 1984
FJI	Dialyzer, Capillary, Hollow Fiber	5	59 days	12 June 1987
FKQ	System, Dialysate Delivery, Central Multiple Patient	5	52 days	16 January 1985
KGO	Surgeon'S Gloves	5	81 days	29 November 1984
KNX	Collector, Urine, (And Accessories) For Indwelling Catheter	5	42 days	29 April 1986
FPB	Filter, Infusion Line	4	39 days	17 April 1987
KOD	Catheter, Urological	4	34 days	8 August 1983
LDR	Controller, Infusion, Intravascular, Electronic	4	37 days	12 February 1986
CAZ	Anesthesia Conduction Kit	3	16 days	17 April 1986
DTZ	Oxygenator, Cardiopulmonary Bypass	3	30 days	18 January 1982
BSY	Catheters, Suction, Tracheobronchial	2	14 days	20 November 1984
CAK	Microfilter, Blood Transfusion	2	19 days	22 October 1987
DIF	Drug Mixture Control Materials	2	18 days	20 July 1982
DTN	Reservoir, Blood, Cardiopulmonary Bypass	2	13 days	13 April 1978
FHS	Dialyzer, Single Coil	2	19 days	26 March 1979
FIL	System, Dialysate Delivery, Single Pass	2	8 days	30 November 1977
FJG	Dialyzer, Parallel Flow	2	38 days	2 May 1979
FLN	Monitor, Electric For Gravity Flow Infusion Systems	2	41 days	4 April 1985
GKT	Separator, Automated, Blood Cell, Diagnostic	2	58 days	31 October 1980

Showing the 25 they file in most, of 77.

Median review is elapsed calendar days between date received and decision date, as published by FDA. It is not FDA review days — the two differ whenever the agency stops the clock for an additional information request.

Source: openFDA device/510k · retrieved 2026-08-11T14:48:53Z

Has Travenol Laboratories, S.A. had a recall?

openFDA lists no recall records naming this company. That is the absence of a record, not a guarantee — and it counts only recalls FDA has published under a spelling we resolved to this company.

Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Recall class I is the most serious kind of recall; device class I is the least risky kind of device, and the two are never mixed here.

Source: openFDA device/recall · retrieved 2026-08-11T14:48:53Z

What has Travenol Laboratories, S.A. cleared recently?

Most recent 510(k) clearances for this company, newest first.
510(k)	Device	Code	Decision	Elapsed days
K874181	BAXTER BEDSIDE SYSTEM	FRN	22 February 1988	131
K873894	CONTINU-FLO SOLUTION W/CHECK VALVE 2 Y-INJECT SITE	FPA	5 November 1987	42
K873873	RESUBMITTED MICRON TRANSFUSION FILTER	CAK	22 October 1987	52
K873984	AUTOMATIC PERITONEAL DIALYSIS CYCLER SET (5C4437)	KDJ	20 October 1987	20
K872364	HEMODIALYSIS (SPS), MODEL 550, CODE 5M1309	FII	13 October 1987	117
K872652	UPGRADED AUTO PERITONEAL DIALYSIS CYCLER SYSTEM	FKX	30 September 1987	85
K870801	FLO-GARD 6200 VOLUMETRIC INFUSION/PUMPING BLOOD	FRN	4 September 1987	189
K871908	IV ADMINISTRATION SET	BRZ	27 July 1987	73
K871471	CAPILLARY FLOW DIALYZERS MODELS ST-12 & ST-15	FJI	12 June 1987	59
K865029	CONTINU-FLO SOLUTION ADMIN. SET W/IN-LINE FILTER	FPB	17 April 1987	115

Source: openFDA device/510k · retrieved 2026-08-11T14:48:53Z

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Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.