Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart E — Cardiovascular Surgical Devices](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices) → [21 CFR 870.4280](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/870.4280) → KRJ — Filter, Prebypass, Cardiopulmonary Bypass

# KRJ · Filter, Prebypass, Cardiopulmonary Bypass

_Cardiovascular · 21 CFR 870.4280 · Class 2_

**Canonical URL:** https://fda.innolitics.com/productcode/KRJ

## Overview

- **Product Code:** KRJ
- **Device Name:** Filter, Prebypass, Cardiopulmonary Bypass
- **Regulation:** [21 CFR 870.4280](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/870.4280)
- **Device Class:** 2
- **Review Panel:** [Cardiovascular](/submissions/CV)

## Identification

A cardiopulmonary prebypass filter is a device used during priming of the oxygenator circuit to remove particulates or other debris from the circuit prior to initiating bypass. The device is not used to filter blood.

## Classification Rationale

Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

## Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

## Recent Cleared Devices (20 of 24)

Showing 20 most recent of 24 cleared devices.

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K990276](/device/K990276.md) | POROUS MEDIA DPB30 SERIES DISPOSABLE PRE-BYPASS FILTER | Porous Media Corp. | Oct 1, 1999 | SESE |
| [K982385](/device/K982385.md) | POROUS MEDIA DPB20 SERIES DISPOSABLE PRE-BYPASS FILTER | Porous Media Corp. | Feb 1, 1999 | SESE |
| [K940126](/device/K940126.md) | AVECOR PRE-BYPASS FILTER | Avecor Cardiovascular, Inc. | Jun 28, 1994 | SESE |
| [K900672](/device/K900672.md) | PREBYPASS FILTER, CAT. NO. FPB-5 | American Omni Medical, Inc. | Apr 3, 1990 | SESE |
| [K885154](/device/K885154.md) | INTERSEPT* CRYSTALLOID CARDIOPLEGIA DELIV. SYSTEM | Medtronic Blood Systems, Inc. | Feb 22, 1989 | SESE |
| [K884390](/device/K884390.md) | INTERSEPT* CRYSTALLOID CARDIOPLEGIA FILTER | Medtronic Blood Systems, Inc. | Dec 21, 1988 | SESE |
| [K884244](/device/K884244.md) | INTERSEPT* PREBYPASS FILTER | Medtronic Blood Systems, Inc. | Dec 5, 1988 | SESE |
| [K883086](/device/K883086.md) | INTERSEPT*PREBYPASS FILTER | Medtronic Blood Systems, Inc. | Sep 16, 1988 | SESE |
| [K875094](/device/K875094.md) | ULTIPOR PRE-BYPASS PLUS FILTER W/POSIDYNE MEMBRANE | Pall Biomedical Products Co. | Feb 29, 1988 | SESE |
| [K871350](/device/K871350.md) | PREBYPASS FILTER | American Omni Medical, Inc. | Jun 8, 1987 | SESE |
| [K861226](/device/K861226.md) | INTERFACE CRYSTALLOID CARDIOPLEGIC FILTER MODEL 70 | Medical, Inc. | Jun 2, 1986 | SESE |
| [K850139](/device/K850139.md) | COBE COP FILTER CARDIOPULMONARY PREBYPASS FILTER | Rapid Diagnostic Laboratories, Inc. | Apr 10, 1985 | SESE |
| [K842141](/device/K842141.md) | SOLUTION CLARIFICATION UNIT | Pall Biomedical Products Co. | Aug 3, 1984 | SESE |
| [K840450](/device/K840450.md) | SHILEY PREBYPASS FILTER | Shiley, Inc. | Apr 17, 1984 | SESE |
| [K832594](/device/K832594.md) | PRE-BYPASS FILTER #EC-PBF SERIES | Gish Biomedical, Inc. | Sep 20, 1983 | SESE |
| [K831286](/device/K831286.md) | ULTIPORE PREBYPASS PLUS FILTER | Pall Biomedical Products Co. | Jun 8, 1983 | SESE |
| [K812539](/device/K812539.md) | PRE-BYPASS FILTER | Gelman Sciences, Inc. | Oct 13, 1981 | SESE |
| [K812244](/device/K812244.md) | INTERFACE PRE BYPASS PRIME FILTER #90 | Medical, Inc. | Aug 25, 1981 | SESE |
| [K812240](/device/K812240.md) | INTERFACE PRE BYPASS PRIME FILTER | Medical, Inc. | Aug 25, 1981 | SESE |
| [K810395](/device/K810395.md) | PRE-BYPASS FILTER | Texas Medical Products, Inc. | Mar 5, 1981 | SESE |

## Top Applicants

- Medtronic Blood Systems, Inc. — 4 clearances
- Medical, Inc. — 3 clearances
- Pall Biomedical Products Co. — 3 clearances
- American Omni Medical, Inc. — 2 clearances
- Bentley Laboratories, Inc. — 2 clearances

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**Source:** [https://fda.innolitics.com/productcode/KRJ](https://fda.innolitics.com/productcode/KRJ)

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