TysonBio LF-TL-28
by Shandong Lianfa Medical Plastic Products CO., LTD
TysonBio LF-TL-28 is a Class II device made by Shandong Lianfa Medical Plastic Products CO., LTD, cleared under FDA 510(k) K222472 on 30 Nov 2022 and listed in FDA GUDID since 16 Jul 2023 (UDI-DI 06949517006386), active as of 22 Oct 2026. One FDA recall is linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
1 ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number06949517006386 | Date16 Jul 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK222472 | Date30 Nov 2022 | StatusActive |
Official records
- AccessGUDID record 06949517006386
- FDA 510(k) database K222472
Across registries
- FDA 510(k) K222472 decided 30 Nov 2022 Active
- FDA GUDID UDI-DI 06949517006386 listed 16 Jul 2023 Listed
Recalls
-
- Ongoing Z-0226-2026
Due to incorrect/lack of Unique Device Identifier (UDI) codes.
Timeline
- Cleared FDA 510(k) K222472
- Listed FDA GUDID 06949517006386
- Recall initiated FDA recalls Z-0226-2026
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- TysonBio
- Generic name
- Blood lancet, single-use
- Model / reference
- LF-TL-28
- Primary DI / UDI-DI
- 06949517006386
- 510(k) Number
- FDA product code
- QRL
- GMDN term
- Blood lancet, single-use
- Device class
- Class II
- Regulation number
- 878.4850
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Blood lancet, single-use.
- ergoLance 8482 by HTL STREFA S A
- Haemolance Plus 7364 by HTL STREFA S A
- BabyLance Safety Heelstick BLN by Clinical Innovations, LLC
- OneTouch Delica Safety 024-209 by Asahi Polyslider Company, Limited
- OneTouch Delica Safety 024-208 by Asahi Polyslider Company, Limited
- Tenderfoot Heel Incision Device TFP1000I by Accriva Diagnostics, Inc.
- Sterile Safety Lancets 5001 by Suzhou Zhenwu Medical Co., Ltd.
- FreeStyle Lancing Device II AT1710EA392 by Owen Mumford Ltd
- HandyRay-Pro LMT-5000 by Lameditech Co., Ltd.
Other devices from Shandong Lianfa Medical Plastic Products Co., Ltd.
See all devices from Shandong Lianfa Medical Plastic Products Co., Ltd. →