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Dose Release Of Sterilization Lots

by Medcare Disp Products, Inc.

510(k) K841949

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 NumberK841949 Date5 Sep 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  • Withdrawn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, 23 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 Dose Release Of Sterilization Lots is a device used to manage the release of sterilized product lots, providing a mechanism to verify that each lot meets required quality and sterility criteria before distribution. It functions as a lot‑release system that records and confirms that sterilization processes have been completed and validated for each batch.

The device was cleared by the FDA through a traditional 510(k) submission (K841949) on 5 September 1984, with a decision of substantially equivalent and classified under product code FMF. It is identified as a Class II medical device and is manufactured by Medcare Disp Products, Inc. in Mchenry, Illinois, United States.

Other devices from Medcare Disp Products, Inc.