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Minncare HD 3031105

by Medivators Inc.

Minncare HD 3031105 is a Class II device made by Medivators Inc., cleared under FDA 510(k) K133724 on 27 Aug 2014 and listed in FDA GUDID since 9 Jan 2018 (UDI-DI 00677964079498), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K133724

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00677964079498 UDI-DI Date9 Jan 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK133724 Date27 Aug 2014DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K133724 decided 27 Aug 2014 Active
  • FDA GUDID UDI-DI 00677964079498 listed 9 Jan 2018 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K133724
  2. Listed FDA GUDID 00677964079498

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Minncare HD
Generic name
Organic peroxy acid device sterilant, single-use
Model / reference
3031105
Primary DI / UDI-DI
00677964079498
510(k) Number
FDA product code
NIH
GMDN term
Organic peroxy acid device sterilant, single-use
Device class
Class II
Regulation number
876.5665
GUDID distribution status
In Commercial Distribution

Related devices

Category: Organic peroxy acid device sterilant, single-use

Cleared under the same submission (K133724)

Other devices from Medivators Inc.

See all devices from Medivators Inc. →

Properties

  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (10, all answered No)