B-D Auto-Injector
FDA 510(k) K974678 · Bd Becton Dickinson Vacutainer Systems Preanalytic
510(k) numberK974678
Submission
- Device name
- B-D Auto-Injector
- Applicant
- Bd Becton Dickinson Vacutainer Systems Preanalytic
Franklin Lakes, NJ, US - Received
- December 15, 1997
- Decision date
- May 29, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KZH – Introducer, Syringe Needle
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.6920
- Specialty
- General Hospital
Other 510(k)s with product code KZH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K243232 | GripMateKZH · Traditional | Synthon Hispania S.L. | 12/02/2024SE |
| K213429 | AccuSert Needle InserterKZH · Traditional | Emed Technologies Corporation | 10/20/2022SE |
| K163400 | Orbit InserterKZH · Traditional | Ypsomed AG | 07/26/2017SE |
| K160860 | MiniMed Quick-serterKZH · Traditional | Medtronic Minimed | 09/22/2016SE |
| K141384 | Whisperject AutoinjectorKZH · Abbreviated | Scandinavian Health Limited | 09/12/2014SE |
| K124026 | Lobster Auto-InjectorKZH · Traditional | Scandinavian Health Limited | 09/13/2013SE |
| K122837 | Autoject 2 for Glassy SyringeKZH · Special | Owen Mumford, Ltd. | 10/15/2012SE |
| K111467 | Flexi-Q DV and DVR Auto-InjectorsKZH · Traditional | Elcam Medical Acal | 02/09/2012SE |
| K082587 | Auto-Safety INJECTOR-2 (ASI-2)KZH · Traditional | Medical House Products Limited | 10/02/2008SE |
| K073476 | Compact Auto-Safety Injector (Casi)KZH · Traditional | Medical House (Asi) Limited | 03/07/2008SE |
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| 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 Auto-Injector cleared by the FDA?
B-D Auto-Injector (K974678) received a 510(k) decision of Substantially Equivalent on May 29, 1998, 165 days after the submission was received.
What is the product code of K974678?
The FDA product code is KZH – Introducer, Syringe Needle, a Class II (moderate risk) device regulated under 21 CFR 880.6920.