Product Code: KRL FDA class 2 21 CFR 870.4205

Detector, Bubble, Cardiopulmonary Bypass

Cardiovascular

This device is a bubble detector for cardiopulmonary bypass, used to detect the presence of air bubbles in the extracorporeal circuit during cardiac surgery, triggering alarms to prevent potentially fatal air embolism from entering the patient's circulation. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket notification. The product code is KRL, regulated under 21 CFR 870.4205 within the Cardiovascular specialty. This device is eligible for third-party review.

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FEI Numbers

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Basic Information

Product Code: KRL
Device Class: FDA class 2
Regulation Number: 870.4205
Medical Specialty: Cardiovascular
Review Panel: CV
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 14 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K103469	STOCKERT AIR PURGE CONTROL SYSTEM MODEL 23-45-05	Jan 18, 2011	Substantially Equivalent	Sorin Group Deutschland GmbH
K090698	CAPIOX BUBBLE TRAP WITH X-COATING	Jun 08, 2009	Substantially Equivalent	Terumo Cardiovascular Systems
K071231	EDAC QUANTIFIER	May 17, 2007	Substantially Equivalent	Luna Innovations, Inc.
K961364	AUTOMATIC TUBING CLAMP SYSTEM (ATC)	Oct 31, 1996	Substantially Equivalent	Rocky Mountain Research, Inc.
K961598	ELS AUTOMATIC TUBING CLAMP SYSTEM	Oct 29, 1996	Substantially Equivalent	Rocky Mountain Research, Inc.
K940651	SARNS ULTRASONIC AIR SENSOR	May 24, 1994	Substantially Equivalent	3M Health Care, Sarns
K935977	SARNS AIR DETECTION SYSTEM	Feb 04, 1994	Substantially Equivalent	3M Health Care, Sarns
K925661	STOCKERT CAPS1 CARDIOPLEGIC CONTROL MODULE	May 18, 1993	Substantially Equivalent	Sorin Biomedica, Fiat, USA, Inc.
K925541	STOCKERT 1/4 BUBBLE SENSOR	Feb 02, 1993	Substantially Equivalent	Sorin Biomedica, Fiat, USA, Inc.
K911632	CAPIOX(R) BUBBLE TRAP	Jul 09, 1991	Substantially Equivalent	Terumo Medical Corp.
K864619	CAPS LOW LEVEL DETECTOR & DETECTOR/BUBBLE MONITOR	Feb 03, 1987	Substantially Equivalent	Shiley, Inc.
K861860	COBE ACCESSORY INTERFACE MODULE (AIM)	Jul 18, 1986	Substantially Equivalent	Cobe Laboratories, Inc.
K842054	COBE AEPS	Aug 02, 1984	Substantially Equivalent	Cobe Laboratories, Inc.
K803102	ARTERIAL BUBBLE TRAP K-20	Dec 22, 1980	Substantially Equivalent	Delta Medical Industries