Skip to content

Bioprime TM Kit

by Hospal

510(k) K892932

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK892932 Date22 Jun 1989ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
FJK
Device Class
Class II
Regulation
21 CFR Part 876.5820
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

This device is a Set, Tubing, Blood, With And Without Anti-Regurgitation Valve. It is classified under medical specialty Gastroenterology, Urology.

It is supplied as a kit, cleared via FDA 510(k) under K892932 with product code FJK, and classified as a Class II device. The device received clearance on June 22, 1989, and is regulated under regulation number 876.5820.

Questions

AI-generated answers, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the BIOPRIME TM KIT used for?

    The BIOPRIME TM KIT is a set of tubing for blood transfer, available with or without an anti-regurgitation valve, designed for use in gastroenterology and urology procedures where controlled fluid flow is required to prevent backflow during blood handling.

  • How is the BIOPRIME TM KIT supplied and is it sterile or single-use?

    The device is supplied as a kit, though the data does not specify sterility or single-use status; users should consult the manufacturer's labeling for details on sterilization method and intended use duration, as these are not stated in the provided authorization or specifications.

  • What regulatory pathway was used for the BIOPRIME TM KIT and what is its classification?

    The BIOPRIME TM KIT received clearance through the FDA 510(k) pathway under submission K892932, is classified as a Class II device, and is regulated under 21 CFR 876.5820 with product code FJK, indicating it was found substantially equivalent to a legally marketed predicate device.