510(k) K222084
- Device
- OneTouch Delica Safety, HemoCue Safety Lancet, Assure Lance And Assure Lance Plus, Capiject Safety Lancet, Heel Lancet Newborn, Heel Lancet Preemie
- Applicant
- Asahi Polyslider Co., Ltd.
- 510(k) number
- K222084
- Product code
- FMK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-11-02
- Date received
- 2022-07-15
- 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
- No
Applicant Contact#
- Contact
- Yoshitaka Akagi
- Address
- 860-2 Misaki Maniwa JP 719-3226 719-3226
FDA Registration Numbers#
- 1066444
- 3002680783
- 3011369203
- 3012598266
- 3011420269
- 3007134734
- 3009109626
- 3004748528
- 3003723176
- 3014649053
- 3001452053
- 3007363438
- 1722458
- 3010132111
- 3021314645
- 3009498548
- 3012172036
- 3010041511
- 3004080548
- 3015347724
- 3015142721
- 3013143994
- 8031690
- 3027529701
- 9617475
- 3010131137
- 3004143450
- 3005862821
- 3030186688
- 3026940910
- 3012026312
- 3022147580
- 3002721930
- 1058602
- 3002807408
- 3004145393
- 3003917514
- 3007384659
- 3007507465
- 3009129531
- 3030691709
- 3005273623
- 3017247483
- 3007594734
- 3006142663
- 3011617315
- 3034603279
- 3001620590
- 9613304
- 3008191276
- 3004168759
- 3016096098
- 3012034017
- 3003965134
- 9611680
- 3008102042
- 3004525100
- 3005280205
- 3002807315
- 3031259044
- 3004513970
- 3007740684
- 3043226252
- 3010162782
- 3011191255
- 3010419931
- 3024273968
- 2954323
- 1217183
- 3008789114
- 1832816
- 3011526299
- 3015058854
- 3013496867
- 3003449582
- 3006446479
- 3021169869
- 2618282
- 3042854290
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 |
| 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 |
Legacy Summary#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases