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One +Step LDE

by Shandong Lianfa Medical Plastic Products CO., LTD 4 variants

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

1 ongoing

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

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number06949517090040 UDI-DI Date22 Apr 2026ListedStatusListed GUDID: in commercial distribution

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.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
One +Step
Generic Name
Manual blood lancing device, reusable
Model / Reference
LDE
Primary DI / UDI-DI
06949517090040
510(k) Number
FDA Product Code
QRK
GMDN Term
Manual blood lancing device, reusable
Device Class
Class II
Regulation Number
878.4850
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K222472)

Show all (12)

Other devices from Shandong Lianfa Medical Plastic Products Co., Ltd.

See all devices from Shandong Lianfa Medical Plastic Products Co., Ltd. →

Properties

  • Convenience Kit
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (10)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No