Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart E — Cardiovascular Surgical Devices](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices) → [21 CFR 870.4205](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/870.4205) → KRL — Detector, Bubble, Cardiopulmonary Bypass

# KRL · Detector, Bubble, Cardiopulmonary Bypass

_Cardiovascular · 21 CFR 870.4205 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/KRL

## Overview

- **Product Code:** KRL
- **Device Name:** Detector, Bubble, Cardiopulmonary Bypass
- **Regulation:** [21 CFR 870.4205](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/870.4205)
- **Device Class:** 2
- **Review Panel:** [Cardiovascular](/submissions/CV)
- **3rd-party reviewable:** yes

## Identification

A cardiopulmonary bypass bubble detector is a device used to detect bubbles in the arterial return line of the cardiopulmonary bypass circuit.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (14 of 14)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K103469](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/KRL/K103469.md) | STOCKERT AIR PURGE CONTROL SYSTEM MODEL 23-45-05 | Sorin Group Deutschland GmbH | Jan 18, 2011 | SESE |
| [K090698](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/KRL/K090698.md) | CAPIOX BUBBLE TRAP WITH X-COATING | Terumo Cardiovascular Systems | Jun 8, 2009 | SESE |
| [K071231](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/KRL/K071231.md) | EDAC QUANTIFIER | Luna Innovations, Inc. | May 17, 2007 | SESE |
| [K961364](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/KRL/K961364.md) | AUTOMATIC TUBING CLAMP SYSTEM (ATC) | Rocky Mountain Research, Inc. | Oct 31, 1996 | SESE |
| [K961598](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/KRL/K961598.md) | ELS AUTOMATIC TUBING CLAMP SYSTEM | Rocky Mountain Research, Inc. | Oct 29, 1996 | SESE |
| [K940651](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/KRL/K940651.md) | SARNS ULTRASONIC AIR SENSOR | 3M Health Care, Sarns | May 24, 1994 | SESE |
| [K935977](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/KRL/K935977.md) | SARNS AIR DETECTION SYSTEM | 3M Health Care, Sarns | Feb 4, 1994 | SESE |
| [K925661](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/KRL/K925661.md) | STOCKERT CAPS1 CARDIOPLEGIC CONTROL MODULE | Sorin Biomedica, Fiat, USA, Inc. | May 18, 1993 | SESE |
| [K925541](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/KRL/K925541.md) | STOCKERT 1/4 BUBBLE SENSOR | Sorin Biomedica, Fiat, USA, Inc. | Feb 2, 1993 | SESE |
| [K911632](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/KRL/K911632.md) | CAPIOX(R) BUBBLE TRAP | Terumo Medical Corp. | Jul 9, 1991 | SESE |
| [K864619](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/KRL/K864619.md) | CAPS LOW LEVEL DETECTOR & DETECTOR/BUBBLE MONITOR | Shiley, Inc. | Feb 3, 1987 | SESE |
| [K861860](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/KRL/K861860.md) | COBE ACCESSORY INTERFACE MODULE (AIM) | Cobe Laboratories, Inc. | Jul 18, 1986 | SESE |
| [K842054](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/KRL/K842054.md) | COBE AEPS | Cobe Laboratories, Inc. | Aug 2, 1984 | SESE |
| [K803102](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/KRL/K803102.md) | ARTERIAL BUBBLE TRAP K-20 | Delta Medical Industries | Dec 22, 1980 | SESE |

## Top Applicants

- Sorin Biomedica, Fiat, USA, Inc. — 2 clearances
- Rocky Mountain Research, Inc. — 2 clearances
- Cobe Laboratories, Inc. — 2 clearances
- 3M Health Care, Sarns — 2 clearances
- Terumo Medical Corp. — 1 clearance

---

**Source:** [https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/KRL](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/KRL)

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