B-D Ultra Fine(R) Lancet
FDA 510(k) K932725 · Bd Becton Dickinson Vacutainer Systems Preanalytic
Submission
- Device name
- B-D Ultra Fine(R) Lancet
- Applicant
- Bd Becton Dickinson Vacutainer Systems Preanalytic
Franklin Lakes, NJ, US - Received
- June 7, 1993
- Decision date
- July 23, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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…
Other 510(k)s with product code FMK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262526 | Safety lancet (XL)FMK · Traditional | Tianjin Huahong Technology Co., Ltd. | 09/13/2026SE |
| K261045 | Verifine Safety LancetsFMK · Special | Promisemed Hangzhou Meditech Co., Ltd. | 05/01/2026SE |
| K260191 | Safety lancet (XXXVII)FMK · Traditional | Tianjin Huahong Technology Co., Ltd. | 03/31/2026SE |
| K253605 | Safety Heel LancetFMK · Traditional | Ningbo Medsun Medical Co., Ltd. | 02/20/2026SE |
| 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 |
|---|---|---|
| K003062 | Bactec Mgit 960 Sir KitsMJA · Traditional | 06/06/2001SE |
| K003553 | 0.9% Sodium Chloride Injection, Usp BD Pre-Filled Flush SyringeFOZ · Traditional | 03/21/2001SE |
| K003461 | BD Vacutainer Passive Shielding Blood Collection NeedleFMI · Traditional | 02/01/2001SE |
| K002938 | B-D Ultra-Fine III Pen Needle; Model 31G X 3/16FMI · Traditional | 11/29/2000SE |
| K001364 | BD Directigen Flu A+BPSZ · Traditional | 06/28/2000SE |
| K000762 | Moxifloxacin, 5 Ug, BBL Sensi-DiscJTN · Traditional | 04/25/2000SE |
| K000829 | Gatifloxacin, 5 Ug, BBL Sensi-DiscJTN · Traditional | 04/13/2000SE |
| K993186 | Synercid, 15 Ug, BBL Sensi-DiscJTN · Traditional | 11/03/1999SE |
| K992734 | Becton Dickinson SyringeMEG · Traditional | 10/01/1999SE |
| K992849 | QBC Star Centrifugal Hematology SystemGKZ · Special | 09/23/1999SE |
Questions and answers
When was B-D Ultra Fine(R) Lancet cleared by the FDA?
B-D Ultra Fine(R) Lancet (K932725) received a 510(k) decision of Substantially Equivalent on July 23, 1993, 46 days after the submission was received.
What is the product code of K932725?
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.