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Sartorius Mini-Sart FH 16555

by Sartorius Filters, Inc.

510(k) K851817

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 NumberK851817 Date19 Aug 1985ClearedStatusActive

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  • Withdrawn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, 26 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 Sartorius Mini-Sart FH 16555 is a filter, infusion line device, substantially equivalent to a predicate device and cleared via the traditional 510(k) pathway. It is classified as a Class II medical device under regulation number 880.5440 and is intended for use in general hospital settings.

The device is supplied by Sartorius Filters, Inc. and is identified by the product code FPB and k-number K851817. It received FDA 510(k) clearance on August 19, 1985, and is registered under multiple facility establishment identifiers and registration numbers as listed in the device data.

Other devices from Sartorius Filters, Inc.

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Questions

AI-generated answers, 26 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 Sartorius Mini-Sart FH 16555 used for?

    The Sartorius Mini-Sart FH 16555 is a filter infusion line device intended for use in general hospital settings, as indicated by its classification under regulation number 880.5440 and its clearance as substantially equivalent to a predicate device.

  • How is the Sartorius Mini-Sart FH 16555 supplied and identified?

    The device is supplied by Sartorius Filters, Inc., identified by the product code FPB and k-number K851817, and was cleared via the traditional 510(k) pathway on August 19, 1985, with multiple facility establishment identifiers and registration numbers associated with its distribution.

  • Is the Sartorius Mini-Sart FH 16555 a single-use or reusable device?

    The device data does not specify whether the Sartorius Mini-Sart FH 16555 is single-use or reusable; therefore, no determination can be made about its reusability based solely on the provided information.