Prebypass Filter Cat.#k-5

No FDA recalls on record, checked 10 Oct 2026.

510(k) Number

K803101 ↗

FDA Product Code

KRJ

Device Class

Class II

Regulation

21 CFR Part 870.4280

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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  Class I

  FDA 510(k) K792182 Active Cleared 15 Nov 1979

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  Class II

  FDA 510(k) K760894 Active Cleared 9 Dec 1976

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  Class II

  FDA 510(k) K801704 Active Cleared 13 Aug 1980

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  FDA 510(k) K830389 Active Cleared 12 Sep 1983

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  Class II

  FDA 510(k) K822761 Active Cleared 30 Sep 1982

• Infusion Pump

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  FDA 510(k) K832470 Active Cleared 28 Feb 1984

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