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Fast Flow XX Aqueous Solution Filter

by Healthtek, Inc.

510(k) K860372

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 NumberK860372 Date30 May 1986ClearedStatusActive

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  • Withdrawn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
FPB
Device Class
Class II
Regulation
21 CFR Part 880.5440
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 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 Fast Flow XX Aqueous Solution Filter is a sterile, single-use device classified as a Filter, Infusion Line. It is designed to remove particulate matter from aqueous solutions during intravenous administration, ensuring the delivery of clear fluids to patients in general hospital settings.

Supplied as a sterile, single-use device, the Fast Flow XX is intended for use in intravenous infusion systems. It adheres to FDA regulation 880.5440 and holds a 510(k) clearance (K860372) under the Traditional pathway, classified as Class II. The device is packaged for one-time use and must be discarded after use to maintain sterility and prevent contamination.

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