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EasyTouch 828101

by MHC Medical Products

EasyTouch 828101 is a Class II device made by MHC Medical Products, cleared under FDA 510(k) K222472 on 30 Nov 2022 and listed in FDA GUDID since 4 Aug 2025 (UDI-DI MHC18281012), active as of 23 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

1 ongoing

Recall on shared 510(k) K222472; other models may be affected

Documents

510(k) K222472

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberMHC18281012 UDI-DI Date4 Aug 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK222472 Date30 Nov 2022DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K222472 decided 30 Nov 2022 Active
  • FDA GUDID UDI-DI MHC18281012 listed 4 Aug 2025 Listed

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-0226-2026 FDA Class III initiated 25 Jul 2025 on shared 510(k) K222472

    Due to incorrect/lack of Unique Device Identifier (UDI) codes.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Timeline

3 dated events

  1. Cleared FDA 510(k) K222472
  2. Recall initiated FDA recalls Z-0226-2026
  3. Listed FDA GUDID MHC18281012

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
EasyTouch
Generic name
Manual blood lancing device, single-use
Model / Ref / Catalog
828101
Primary DI / UDI-DI
MHC18281012
510(k) Number
FDA product code
QRK
GMDN term
Manual blood lancing device, single-use
Device class
Class II
Regulation number
878.4850
GUDID distribution status
In Commercial Distribution

Related devices

Category: Manual blood lancing device, single-use

Cleared under the same submission (K222472)

and 8 more cleared under K222472

Similar devices

Other devices filed under FDA product code QRK (Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature).

Other devices from MHC Medical Products

See all devices from MHC Medical Products →

Properties

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