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FLU-VEN TK-2

by Venospital, Inc.

510(k) K791130

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK791130 Date4 Sep 1979ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 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  • Withdrawn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
KSB
Device Class
Class II
Regulation
21 CFR Part 864.9875
Advisory Committee
Hematology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 Sep 2026

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

The FLU-VEN TK-2 is a Set, Transfer (Blood/Plasma) device as defined in the device name and classification data. It is classified under device class 2 with product code KSB and regulation number 864.9875, and is associated with the hematology medical specialty.

The device received FDA 510(k) clearance under K791130 on September 4, 1979, following a traditional submission received on June 18, 1979. It was found substantially equivalent (SESE) and is manufactured by Venospital, Inc. in McHenry, Illinois, United States.

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