BD Eclipse Bifurcated Needle
FDA 510(k) K032528 · Becton, Dickinson & CO
510(k) numberK032528
Submission
- Device name
- BD Eclipse Bifurcated Needle
- Applicant
- Becton, Dickinson & CO
Franklin Lakes, NJ, US - Received
- August 15, 2003
- Decision date
- September 9, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) statement 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 |
| K222385 | Bifurcated NeedleSCL · Traditional | Anhui Tiankang Medical Technology Co., Ltd. | 12/06/2022SE |
| 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 |
| 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 |
|---|---|---|
| K243062 | BD Intelliport System; BD Intelliport Reader (516230); BD Intelliport Sensor (516229)…PHC · Traditional | 06/20/2025SE |
| K170386 | BD Ultra-Fine Insulin Syringe, BD Ultra-Fine II Insulin Syringe, BD Insulin Syringes…FMF · Special | 04/12/2017SE |
| K163637 | BD Phoenix Automated Microbiology System - GN Ceftazidime/avibactam (0.25/4- 32/4ug/mL)LON · Traditional | 03/21/2017SE |
| K161810 | BD BACTEC Standard/10 Aerobic/F Culture Vials Soybean-Casein Digest Broth in a Plastic…MDB · Traditional | 02/09/2017SE |
| K161306 | BD BACTEC Standard Anaerobic/F Culture Vials Soybean-Casein Digest Broth in a Plastic VialMDB · Traditional | 08/08/2016SE |
| K160164 | BD Veritor System for Rapid Detection of Flu A + B Labratory KitPSZ · Special | 02/25/2016SE |
| K160161 | BD Veritor System for Rapid Detection of Flu A + B CLIA waived kitPSZ · Special | 02/24/2016SE |
| K150059 | BD FlowSmart SetFPA · Traditional | 04/28/2015SE |
| K141474 | Becton Dickinson Intelliport SystemPHC · Traditional | 12/18/2014SE |
| K140448 | BD Probetec Neisseria Gonorrhoeae (GC) QX Amplified DNA AssayLSL · Traditional | 05/20/2014SE |
Questions and answers
When was BD Eclipse Bifurcated Needle cleared by the FDA?
BD Eclipse Bifurcated Needle (K032528) received a 510(k) decision of Substantially Equivalent on September 9, 2003, 25 days after the submission was received.
What is the product code of K032528?
The FDA product code is SCL – Allergen And Vaccine Delivery Needles, a Class II (moderate risk) device regulated under 21 CFR 880.5570.