Lancet, Blood
FDA 510(k) K883420 · Primrose Medical, Inc.
Submission
- Device name
- Lancet, Blood
- Applicant
- Primrose Medical, Inc.
Woburn, MA, US - Received
- August 15, 1988
- Decision date
- August 26, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FMK – Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4850
- Specialty
- General, Plastic Surgery
A disposable blood lancet intended for a single use that is comprised of a single use blade attached to a solid, non-reusable base (including an integral sharps injury prevention feature) that is used to puncture the skin to obtain a drop of blood for diagnostic purposes. The integral sharps injury prevention feature allows the device to be used once and then renders it inoperable and incapable…
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| K262526 | Safety lancet (XL)FMK · Traditional | Tianjin Huahong Technology Co., Ltd. | 09/13/2026SE |
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| K252490 | Heel Stick Safety Lancet (HHZ-II, HHZ-III, HHZ-IV)FMK · Special | Tianjin Huahong Technology Co., Ltd. | 02/12/2026SE |
| K251694 | safety lancetFMK · Special | Tianjin Huahong Technology Co., Ltd. | 06/26/2025SE |
| K244036 | Heel Incision Safety Lancet (SteriHeel 2)FMK · Traditional | SteriLance Medical (Suzhou), Inc. | 02/26/2025SE |
| K243533 | Sterilized Eol Auto Lancet; Sterilized Eol Lancet PlusFMK · Traditional | Hlb Co., Ltd. Healthcare | 01/13/2025SE |
| K242680 | LetsGetChecked ImpressFMK · Traditional | Privapath Diagnostics Ltd (Dba Letsgetchecked) | 01/13/2025SESU |
| K242664 | gentleheel® Adult Incision DeviceFMK · Traditional | Gri-Alleset, Inc. | 11/05/2024SE |
More from Gri-Alleset, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K884715 | Achelasia Balloon DialatorKNQ · Traditional | 09/29/1989SE |
| K884714 | Biliary DialatorFGE · Traditional | 09/29/1989SE |
| K884713 | Colonic Balloon DialatorsFFP · Traditional | 09/29/1989SE |
| K884711 | Urethral and Ureteral Balloon DilatatorsEZN · Traditional | 09/29/1989SE |
| K884712 | Esophageal and Pyloric Balloon DialatorsKNQ · Traditional | 09/08/1989SE |
| K884709 | Endoscopes & Access.(Sclerotherapy/Transbronchial)ODD · Traditional | 09/08/1989SE |
| K881976 | Catheter, IntravascularFOZ · Traditional | 08/04/1988SE |
| K881977 | Pressure InfusorKZD · Traditional | 07/29/1988SE |
| K881975 | Set, IntravascularFPA · Traditional | 07/29/1988SE |
| K881978 | Enteral Feeding TubesKNT · Traditional | 07/13/1988SE |
Questions and answers
When was Lancet, Blood cleared by the FDA?
Lancet, Blood (K883420) received a 510(k) decision of Substantially Equivalent on August 26, 1988, 11 days after the submission was received.
What is the product code of K883420?
The FDA product code is FMK – Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature, a Class II (moderate risk) device regulated under 21 CFR 878.4850.