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/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/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](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/KRJ/K990276.md) | POROUS MEDIA DPB30 SERIES DISPOSABLE PRE-BYPASS FILTER | Porous Media Corp. | Oct 1, 1999 | SESE | | [K982385](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/KRJ/K982385.md) | POROUS MEDIA DPB20 SERIES DISPOSABLE PRE-BYPASS FILTER | Porous Media Corp. | Feb 1, 1999 | SESE | | [K940126](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/KRJ/K940126.md) | AVECOR PRE-BYPASS FILTER | Avecor Cardiovascular, Inc. | Jun 28, 1994 | SESE | | [K900672](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/KRJ/K900672.md) | PREBYPASS FILTER, CAT. NO. FPB-5 | American Omni Medical, Inc. | Apr 3, 1990 | SESE | | [K885154](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/KRJ/K885154.md) | INTERSEPT* CRYSTALLOID CARDIOPLEGIA DELIV. SYSTEM | Medtronic Blood Systems, Inc. | Feb 22, 1989 | SESE | | [K884390](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/KRJ/K884390.md) | INTERSEPT* CRYSTALLOID CARDIOPLEGIA FILTER | Medtronic Blood Systems, Inc. | Dec 21, 1988 | SESE | | [K884244](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/KRJ/K884244.md) | INTERSEPT* PREBYPASS FILTER | Medtronic Blood Systems, Inc. | Dec 5, 1988 | SESE | | [K883086](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/KRJ/K883086.md) | INTERSEPT*PREBYPASS FILTER | Medtronic Blood Systems, Inc. | Sep 16, 1988 | SESE | | [K875094](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/KRJ/K875094.md) | ULTIPOR PRE-BYPASS PLUS FILTER W/POSIDYNE MEMBRANE | Pall Biomedical Products Co. | Feb 29, 1988 | SESE | | [K871350](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/KRJ/K871350.md) | PREBYPASS FILTER | American Omni Medical, Inc. | Jun 8, 1987 | SESE | | [K861226](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/KRJ/K861226.md) | INTERFACE CRYSTALLOID CARDIOPLEGIC FILTER MODEL 70 | Medical, Inc. | Jun 2, 1986 | SESE | | [K850139](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/KRJ/K850139.md) | COBE COP FILTER CARDIOPULMONARY PREBYPASS FILTER | Rapid Diagnostic Laboratories, Inc. | Apr 10, 1985 | SESE | | [K842141](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/KRJ/K842141.md) | SOLUTION CLARIFICATION UNIT | Pall Biomedical Products Co. | Aug 3, 1984 | SESE | | [K840450](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/KRJ/K840450.md) | SHILEY PREBYPASS FILTER | Shiley, Inc. | Apr 17, 1984 | SESE | | [K832594](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/KRJ/K832594.md) | PRE-BYPASS FILTER #EC-PBF SERIES | Gish Biomedical, Inc. | Sep 20, 1983 | SESE | | [K831286](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/KRJ/K831286.md) | ULTIPORE PREBYPASS PLUS FILTER | Pall Biomedical Products Co. | Jun 8, 1983 | SESE | | [K812539](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/KRJ/K812539.md) | PRE-BYPASS FILTER | Gelman Sciences, Inc. | Oct 13, 1981 | SESE | | [K812244](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/KRJ/K812244.md) | INTERFACE PRE BYPASS PRIME FILTER #90 | Medical, Inc. | Aug 25, 1981 | SESE | | [K812240](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/KRJ/K812240.md) | INTERFACE PRE BYPASS PRIME FILTER | Medical, Inc. | Aug 25, 1981 | SESE | | [K810395](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/KRJ/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 --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/KRJ](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/KRJ) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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