OneTouch Delica Safety, HemoCue Safety Lancet, Assure Lance and Assure Lance Plus, Capiject Safety Lancet, Heel Lancet Newborn, Heel Lancet Preemie
FDA 510(k) clearance K222084 · decided 2022-11-02
Clearance details
- K-number
- K222084
- Device name
- 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.
- Decision
- Substantially Equivalent
- Date received
- 2022-07-15
- Decision date
- 2022-11-02
- Days to decision
- 110 days
- Clearance type
- Traditional
- Product code
- FMK
- Device class
- 2
- Regulation number
- 878.4850
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Maniwa, JP
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Verifine Safety Lancets (K261045) | Promisemed Hangzhou Meditech Co., Ltd. | 2026-05-01 |
| Safety lancet (XXXVII) (K260191) | Tianjin Huahong Technology Co., Ltd. | 2026-03-31 |
| Safety Heel Lancet (K253605) | Ningbo Medsun Medical Co., Ltd. | 2026-02-20 |
| Heel Stick Safety Lancet (HHZ-II, HHZ-III, HHZ-IV) (K252490) | Tianjin Huahong Technology Co., Ltd. | 2026-02-12 |
| safety lancet (K251694) | Tianjin Huahong Technology Co., Ltd. | 2025-06-26 |
| Heel Incision Safety Lancet (SteriHeel 2) (K244036) | SteriLance Medical (Suzhou), Inc. | 2025-02-26 |
| LetsGetChecked Impress (K242680) | Privapath Diagnostics Ltd (Dba Letsgetchecked) | 2025-01-13 |
| Sterilized Eol Auto Lancet; Sterilized Eol Lancet Plus (K243533) | Hlb Co., Ltd. Healthcare | 2025-01-13 |
| gentleheelĀ® Adult Incision Device (K242664) | Gri-Alleset, Inc. | 2024-11-05 |
| Safety Lancet (K242627) | Ningbo Medsun Medical Co., Ltd. | 2024-10-30 |
| Safety Lancet (K242316) | Ningbo Medsun Medical Co., Ltd. | 2024-08-28 |
| MedtFine Safety Lancet (K241848) | Ningbo Caremed Medical Products Co., Ltd. | 2024-08-20 |
Recalls involving this device
No recalls on record reference this clearance.