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Easy Breather Header Bags

by Medical Industries Packaging, Inc.

510(k) K830961

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 NumberK830961 Date12 Apr 1983ClearedStatusActive

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  • Withdrawn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
KCT
Device Class
Class II
Regulation
21 CFR Part 880.6850
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 Easy Breather Header Bags are Sterilization Wrap Containers designed to protect medical devices and trays during sterilization and storage. These bags provide a barrier against contamination, moisture, and light, ensuring the integrity of packaged items until use.

Supplied as single-use items, these header bags are intended for use in general hospital settings and are classified under FDA product code KCT. They require FDA 510(k) clearance (K830961) and are regulated under the Sterilization Wrap Containers, Trays, Cassettes & Other Accessories category (Regulation 880.6850). No third-party review was involved in their authorization.

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