510(k) K241750
- Device
- Medifun Safety Lancet ( MSL1 series)
- Applicant
- Medifun Corporation
- 510(k) number
- K241750
- Product code
- FMK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-08-15
- Date received
- 2024-06-18
- Regulation
- 878.4850
- Classification name
- Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Aaron Chen
- Address
- 4f-1, 4f-9, 4f-10, #99, Jingke S. Rd., Nantun Dist., Taichung City TW 408 408
FDA Registration Numbers#
- 3010131137
- 3003965134
- 3007185216
- 3005280205
- 3014649053
- 3038610665
- 3007499349
- 3011369203
- 3013188547
- 3011088743
- 9617475
- 3013496867
- 3021314645
- 2243072
- 8031690
- 3012172036
- 3003723176
- 3001452053
- 3004748528
- 3013546453
- 3011137372
- 3004143450
- 3010419931
- 3011420269
- 3004168759
- 3042854290
- 3008700497
- 9615507
- 3015058854
- 3015347724
- 3031259044
- 3005862821
- 3030691709
- 3014579161
- 8020040
- 3038184658
- 3001620590
- 3007740684
- 3007382160
- 3031789039
- 3009498548
- 3012034017
- 3038772401
- 3044026004
- 1417592
- 3030186688
- 3017210488
- 3017923561
- 3007134734
- 9611680
- 3008191276
- 3010162782
- 2618282
- 3043226252
- 3005798905
- 3002773714
- 3026211706
- 3013019728
- 3015142721
- 3003449582
- 3013557562
- 3009498536
- 3010041511
- 3002807408
- 3010194621
- 3021169869
- 3008337059
- 3003348846
- 3006210673
- 3002807315
- 3012348571
- 1722684
- 3011845225
- 3007363438
- 3009578786
- 3011617315
- 1058602
- 3009129531
- 3015209536
Source Documents#
Other 510(k) Records For Product Code FMK#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261045 | Verifine Safety Lancets | Promisemed Hangzhou Meditech Co., Ltd. | 2026-05-01 |
| K260191 | Safety lancet (XXXVII) | Tianjin Huahong Technology Co., Ltd. | 2026-03-31 |
| K253605 | Safety Heel Lancet | Ningbo Medsun Medical Co., Ltd. | 2026-02-20 |
| K252490 | Heel Stick Safety Lancet (HHZ-II, HHZ-III, HHZ-IV) | Tianjin Huahong Technology Co., Ltd. | 2026-02-12 |
| K251694 | safety lancet | Tianjin Huahong Technology Co., Ltd. | 2025-06-26 |
| K244036 | Heel Incision Safety Lancet (SteriHeel 2) | SteriLance Medical (Suzhou), Inc. | 2025-02-26 |
| K243533 | Sterilized Eol Auto Lancet; Sterilized Eol Lancet Plus | Hlb Co., Ltd. Healthcare | 2025-01-13 |
| K242680 | LetsGetChecked Impress | Privapath Diagnostics Ltd (Dba Letsgetchecked) | 2025-01-13 |
| K242664 | gentleheel® Adult Incision Device | Gri-Alleset, Inc. | 2024-11-05 |
| K242627 | Safety Lancet | Ningbo Medsun Medical Co., Ltd. | 2024-10-30 |
| K242316 | Safety Lancet | Ningbo Medsun Medical Co., Ltd. | 2024-08-28 |
| K241848 | MedtFine Safety Lancet | Ningbo Caremed Medical Products Co., Ltd. | 2024-08-20 |
| K241627 | Safety Lancet (XXXV) | Tianjin Huahong Technology Co., Ltd. | 2024-06-20 |
| K240806 | Safety lancet (XXVIII, XXIX, XXX, XXXI, XXXII, XXXIII, XXXIV.) | Tianjin Huahong Technology Co., Ltd. | 2024-05-21 |
| K234081 | RedDrop ONE (One) | Reddrop DX | 2024-03-21 |