Prebypass Filter

No FDA recalls on record, checked 11 Oct 2026.

510(k) Number

K780485 ↗

FDA Product Code

KRJ

Device Class

Class II

Regulation

21 CFR Part 870.4280

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Ice Container I.C.E.

  Class I

  FDA 510(k) K792182 Active Cleared 15 Nov 1979

• Prebypass Filter Cat.#k-5

  Class II

  FDA 510(k) K803101 Active Cleared 22 Dec 1980

• Vacuum Relief Valve (K760894)

  Class II

  FDA 510(k) K760894 Active Cleared 9 Dec 1976

• Open-Loop Insulin Delivery System

  Class II

  FDA 510(k) K801704 Active Cleared 13 Aug 1980

• Accu-Rynge Pump Sp-250

  Class II

  FDA 510(k) K830389 Active Cleared 12 Sep 1983

• Delivery Tube Set #2226

  Class II

  FDA 510(k) K822761 Active Cleared 30 Sep 1982

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