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Iv Jet

by Nuclear Concepts, Inc.

510(k) K843887

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 NumberK843887 Date7 Dec 1984ClearedStatusActive

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  • Withdrawn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, 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.

The Iv Jet is a medical device categorized under the product code FMF. It is designed for use within a general hospital setting.

This device is supplied by Nuclear Concepts, Inc. and received FDA 510(k) clearance on December 7, 1984, under the reference number K843887.

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 intended use of the IV Jet?

    The IV Jet is designed for use within a general hospital setting. It is categorized under product code FMF, which relates to devices reviewed by the General Hospital advisory committee.

  • What is the regulatory status of the IV Jet?

    The IV Jet received FDA 510(k) clearance on December 7, 1984. The device was determined to be substantially equivalent to existing products under the reference number K843887.

  • Who is the manufacturer of the IV Jet?

    The IV Jet is manufactured by Nuclear Concepts, Inc., located in Danbury, Connecticut. The company submitted the device for review, which resulted in a traditional 510(k) clearance.