Bifurcated Needle
FDA 510(k) K222385 · Anhui Tiankang Medical Technology Co., Ltd.
510(k) numberK222385
Submission
- Device name
- Bifurcated Needle
- Applicant
- Anhui Tiankang Medical Technology Co., Ltd.
Tianchang, CN - Received
- August 8, 2022
- Decision date
- December 6, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- SCL – Allergen And Vaccine Delivery Needles
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5570
- Specialty
- General Hospital
An allergen delivery needle is a device intended to percutaneously deliver diagnostic allergenic extracts for use in allergy skin tests also referred to as skin prick tests or intradermal allergy tests.
Other 510(k)s with product code SCL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K250983 | Medblue Skin Prick Test Applicator (AS103, AS108, AS109, AS110, AS111, AS113, AS132…SCL · Traditional | Asistan Medikal | 01/30/2026SE |
| K182582 | Oryum and Ovem Epidermal Deri Prick Test ApplicatorSCL · Traditional | Allergy & Applicator Depot, LLC | 04/10/2019SE |
| K172062 | AllergiEnd ST-9 Multiple Skin Test Applicator, AllergiEnd ST-9 Multiple Well Test TraySCL · Traditional | Medscience Science Research Group, Inc. | 03/05/2018SE |
| K162917 | Allerhope Allergy Skin TesterSCL · Traditional | Procare Industrial Co., Limited | 08/17/2017SE |
| K032528 | BD Eclipse Bifurcated NeedleSCL · Special | Becton, Dickinson & CO | 09/09/2003SE |
| K031630 | Bifurcated Allergy Skin Testing NeedleSCL · Traditional | Precision Medical Products, Inc. | 08/07/2003SE |
| K020523 | BD Bifurcated Needle, Models 301754, 301755, 301756, 301757SCL · Traditional | Bd | 03/20/2002SE |
| K020500 | Univec Bifurcated Sliding Sheath SyringeSCL · Traditional | Univec, Inc. | 03/19/2002SE |
| K012515 | Bifurcated Vaccinating NeedleSCL · Traditional | Precision Medical Products, Inc. | 09/19/2001SE |
| K011979 | Allersharp Allergy Skin TesterSCL · Traditional | Hmb Medical Concepts, Ltd. | 09/14/2001SE |
More from Hmb Medical Concepts, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K222773 | Feeding TubePIF · Traditional | 08/17/2023SE |
| K222772 | Oral/Enteral Syringe with ENFit connectorPNR · Traditional | 08/17/2023SE |
| K230756 | TK Pre-Filled Normal Saline Flush SyringeNGT · Traditional | 08/12/2023SE |
| K220204 | Disposabel Syringe with permanently attached needle, Safety Syringe with permanently…FMF · Traditional | 07/14/2022SE |
| K212368 | Surgical Face MaskFXX · Traditional | 10/24/2021SE |
| K210464 | Auto Disable SyringeFMF · Traditional | 08/24/2021SE |
| K191639 | TK Insulin Syringe with/without Saftey Retractable DeviceMEG · Traditional | 09/11/2020SE |
| K191640 | TK Intravascular Administration SetFPA · Traditional | 08/26/2020SE |
| K191644 | TK Safety NeedleFMI · Traditional | 08/06/2020SE |
| K191642 | TK Sterile Piston Syringe without NeedleFMF · Traditional | 01/06/2020SE |
Questions and answers
When was Bifurcated Needle cleared by the FDA?
Bifurcated Needle (K222385) received a 510(k) decision of Substantially Equivalent on December 6, 2022, 120 days after the submission was received.
What is the product code of K222385?
The FDA product code is SCL – Allergen And Vaccine Delivery Needles, a Class II (moderate risk) device regulated under 21 CFR 880.5570.