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HEC 1000

by Metro Medical Equipment, Inc.

510(k) K020466

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 NumberK020466 Date8 May 2002ClearedStatusActive

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  • Withdrawn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
KPJ
Device Class
Class II
Regulation
21 CFR Part 878.5650
Advisory Committee
General, Plastic Surgery
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 HEC 1000 is a Chamber, Oxygen, Topical, Extremity device, classified as a Class II medical device under FDA regulation 878.5650. It is substantially equivalent to a predicate device and was cleared via the traditional 510(k) pathway under K020466.

The device is supplied by Metro Medical Equipment, Inc. and is intended for use in general and plastic surgery settings. It is not described as sterile, single-use, reusable, or MRI safe in the provided data, and no specific sizes, storage conditions, or additional authorisations beyond the FDA 510(k) clearance are specified.

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 HEC 1000 used for?

    The HEC 1000 is intended for use in general and plastic surgery settings as a chamber for oxygen delivery to topical extremities, based on its classification under FDA regulation 878.5650.

  • How is the HEC 1000 supplied and is it sterile or single-use?

    The HEC 1000 is supplied by Metro Medical Equipment, Inc., but the provided data does not specify whether it is sterile, single-use, or reusable, so no determination can be made from the available information.

  • What regulatory pathway was used for the HEC 1000?

    The HEC 1000 was cleared via the traditional 510(k) pathway under K020466, demonstrating substantial equivalence to a predicate device as a Class II medical device.