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Hemo-Sanitas Syringe

by Hemo-Sanitas, Inc. C/O Greenberg Irwin & Weisinger

510(k) K884921

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 NumberK884921 Date9 Feb 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  • Withdrawn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
FMF
Device Class
Class II
Regulation
21 CFR Part 880.5860
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 28 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 Hemo-Sanitas Syringe is a medical device used for the administration of fluids or medications. It is a syringe designed for general hospital use.

The device is supplied by Hemo-Sanitas, Inc. and has FDA 510(k) clearance with number K884921. It is regulated under product code FMF and was cleared as substantially equivalent in 1989.

Questions

AI-generated answers, 28 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 Hemo-Sanitas Syringe used for?

    The Hemo-Sanitas Syringe is a medical device designed for the administration of fluids or medications in general hospital settings. It is intended for standard medical procedures requiring precise delivery of substances.

  • How is the Hemo-Sanitas Syringe supplied?

    The Hemo-Sanitas Syringe is supplied by Hemo-Sanitas, Inc. It is manufactured and distributed as a single-use device, though the description does not specify packaging quantities or configurations.

  • What is the regulatory status of the Hemo-Sanitas Syringe?

    The Hemo-Sanitas Syringe has FDA 510(k) clearance with number K884921. It was cleared as substantially equivalent in 1989 and is regulated under product code FMF for general hospital use.

  • What sizes and models of the Hemo-Sanitas Syringe are available?

    The device data does not specify available sizes or models of the Hemo-Sanitas Syringe. The information provided only confirms it is designed for general hospital use without detailing specific volume capacities or variations.