510(k) K243533
- Device
- Sterilized Eol Auto Lancet; Sterilized Eol Lancet Plus
- Applicant
- Hlb Co., Ltd. Healthcare
- 510(k) number
- K243533
- Product code
- FMK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-01-13
- Date received
- 2024-11-15
- 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
- N
Related Records
Applicant Contact
- Contact
- Seung-won Baek
- Address
- 10-5, Myeonghaksandanseo-Ro, Yeondong-Myeon Sejong-Si KR 30068 30068
FDA Registration Numbers
- 3038356900
- 3014383302
- 1066444
- 3002807315
- 3010162782
- 3006142663
- 3021286079
- 3004145393
- 3006210673
- 3007384659
- 3021169869
- 3013188547
- 3026211706
- 3003449582
- 3001620590
- 3005862821
- 1722458
- 3015142721
- 1722684
- 3002807112
- 3031789039
- 3030896267
- 9614157
- 3004080548
- 3013557562
- 3002808145
- 3039524238
- 3010131137
- 3012026312
- 3008700497
- 3016096098
- 3027529701
- 3010515547
- 3003902721
- 3008789114
- 3004143450
- 9611680
- 3003917514
- 3022147580
- 3017210488
- 3030186688
- 3013019728
- 3009498548
- 3012348571
- 8021764
- 3009129531
- 3024273968
- 3010132111
- 3015140199
- 3013546453
- 8020040
- 3003348846
- 3009171251
- 3026940910
- 3003807268
- 2954323
- 3008382007
- 3007594734
- 2531491
- 1058584
- 3017247483
- 3014150341
- 3011420269
- 3001058982
- 3012172036
- 3007740684
- 8031690
- 3011191255
- 3008337059
- 3034603279
- 3014579161
- 1417592
- 3043534762
- 3013496867
- 3038610665
- 3021244152
- 3031259044
- 3003965134
- 3012598266
Source Documents
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08809262393743 | SureComfort Safety Lancet | HLB CO.,LTD | 2025-08-20 |
| 08809262393910 | Sterilized Eol Lancet Plus | HLB CO.,LTD | 2025-08-20 |
| 08809262393897 | Sterilized Eol Auto Lancet | HLB CO.,LTD | 2025-08-20 |
| 08809262393880 | Sterilized Eol Auto Lancet | HLB CO.,LTD | 2025-08-20 |
| 08809262393873 | Sterilized Eol Auto Lancet | HLB CO.,LTD | 2025-08-20 |
| 08809262393934 | Sterilized Eol Lancet Plus | HLB CO.,LTD | 2025-08-20 |
| 08809262393927 | Sterilized Eol Lancet Plus | HLB CO.,LTD | 2025-08-20 |
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 |
| 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 |
| K241750 | Medifun Safety Lancet ( MSL1 series) | Medifun Corporation | 2024-08-15 |
| 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 |