Vacutainer Brand Blood Collection Syringe
FDA 510(k) K982922 · Becton Dickinson Vacutainer Systems
510(k) numberK982922
Submission
- Device name
- Vacutainer Brand Blood Collection Syringe
- Applicant
- Becton Dickinson Vacutainer Systems
Franklin Lake, NJ, US - Received
- August 19, 1998
- Decision date
- September 22, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JKA – Tubes, Vials, Systems, Serum Separators, Blood Collection
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1675
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JKA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252899 | Female Culture Device; Male Culture Device; Transfer Device; Access DeviceJKA · Traditional | Zhejiang Kindly Medical Device Co., Ltd. | 06/02/2026SE |
| K260128 | BD Preset and BD A-Line Arterial Blood Collection SyringesJKA · Special | Becton, Dickinson and Company | 04/15/2026SE |
| K252506 | BD Vacutainer® Safety-Lok Blood Collection Set; BD Vacutainer® Safety-Lok Blood…JKA · Traditional | Becton, Dickinson and Company | 04/10/2026SE |
| K252378 | BD® MiniDraw Capillary Blood Collection System with BD® MiniDraw SST Capillary Blood…JKA · Traditional | Becton, Dickinson and Company | 04/10/2026SE |
| K252040 | BD Vacutainer® Plasma Separator Tubes (PST), BD Vacutainer® Sodium Heparin Blood…JKA · Traditional | Becton, Dickinson and Company | 03/13/2026SE |
| K251812 | Steripath® Flow Blood Collection SystemJKA · Traditional | Magnolia Medical Technologies | 09/25/2025SE |
| K243207 | BD Vacutainer® Eclipse Blood Collection NeedleJKA · Traditional | Becton, Dickinson and Company | 07/03/2025SE |
| K250961 | Blood collection tube holdersJKA · Traditional | Promisemed Hangzhou Meditech Co., Ltd. | 06/04/2025SE |
| K244047 | Navi Needle-free Blood Collection Device (VNC20500FG, VNC22500FG, VNC24500FG)JKA · Traditional | Venocare, Inc. | 05/23/2025SE |
| K250907 | Sol-Guard TM XtraThin Safety Pull-Button Blood Collection SetJKA · Special | Sol-Millennium Medical, Inc. | 04/30/2025SE |
More from Sol-Millennium Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K002456 | Microtainer Brand Sodium Fluoride/Edta Tube with Microgard Closure, Model 365992JKA · Traditional | 11/02/2000SE |
| K991702 | Microtainer Brand Chemistry Tubes with Microgard Closure, Model 365965, 365985, 365963…JKA · Traditional | 07/28/1999SE |
| K991088 | Vacutainer Brand Multiple Sample Luer Adapter, Blood Collection Sets and Safety-Lok…JKA · Traditional | 05/28/1999SE |
| K991120 | Vacutainer Brand Ctad Tube (Multiple)JKA · Traditional | 05/19/1999SE |
| K982541 | Vacutainer Brand Eclipse Blood Collection Needle, Models# 368607 & 368608FMI · Traditional | 10/28/1998SE |
| K981013 | Vacutainer Plus Tube with Edta Anticoagulant Andd Vacutainer Plus Serum TubeJKA · Traditional | 06/17/1998SN |
| K972075 | Vacutainer Brand PPT Plasma Preparation TubePJE · Traditional | 02/24/1998SE |
| K980098 | Vacutainer Brand Pronto Needles HolderJKA · Traditional | 02/05/1998SE |
| K971449 | Vacutainer Brand Plus Tube with Edta Anticoagulant(Multiple)GIM · Traditional | 06/17/1997SE |
| K960250 | Vacutainer Brand Plus Serum & SST TubesJKA · Traditional | 03/29/1996SE |
Questions and answers
When was Vacutainer Brand Blood Collection Syringe cleared by the FDA?
Vacutainer Brand Blood Collection Syringe (K982922) received a 510(k) decision of Substantially Equivalent on September 22, 1998, 34 days after the submission was received.
What is the product code of K982922?
The FDA product code is JKA – Tubes, Vials, Systems, Serum Separators, Blood Collection, a Class II (moderate risk) device regulated under 21 CFR 862.1675.