Vacutainer Brand Eclipse Blood Collection Needle, Models# 368607 & 368608
FDA 510(k) K982541 · Becton Dickinson Vacutainer Systems
510(k) numberK982541
Submission
- Device name
- Vacutainer Brand Eclipse Blood Collection Needle, Models# 368607 & 368608
- Applicant
- Becton Dickinson Vacutainer Systems
Franklin Lake, NJ, US - Received
- July 21, 1998
- Decision date
- October 28, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FMI – Needle, Hypodermic, Single Lumen
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5570
- Specialty
- General Hospital
Other 510(k)s with product code FMI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261719 | Promisemed X-Safety Pen NeedleFMI · Special | Promisemed Hangzhou Meditech Co., Ltd. | 08/25/2026SE |
| K262427 | Pen Needle (Ordinary Type I, Safety Type IIA, Safety Type IIB, Safety Type IIIA, Safety…FMI · Special | Hh Global Technology, Inc. | 08/10/2026SE |
| K260933 | Safety Sterile Hypodermic Needles (NR-S1816R, NR-S1916R, NR-S1925R, NR-S1938R…FMI · Traditional | Hangzhou Qiantang Longyue Biotechnology Co., Ltd. | 08/07/2026SE |
| K261829 | Profoject Dual-Safety Pen NeedlesFMI · Traditional | CMT Health PTE., Ltd. | 07/29/2026SE |
| K260739 | Profoject Pen Needles (Model A; Model B)FMI · Traditional | CMT Health PTE., Ltd. | 07/15/2026SE |
| K260855 | Profoject Safety Pen NeedlesFMI · Traditional | CMT Health PTE., Ltd. | 06/10/2026SE |
| K254273 | Verisafe Safety Sterile Needles (SSN)FMI · Special | Promisemed Hangzhou Meditech Co., Ltd. | 04/16/2026SE |
| K252908 | Easydrip Classic Pen Needle; Easydrip Plus Pen Needle; Easydrip Classic Pro Pen Needle…FMI · Special | Sandstone Medical (Suzhou), Inc. | 03/25/2026SE |
| K253047 | PressoneFMI · Traditional | Nipro Medical Corporation | 03/24/2026SE |
| K253622 | Safety Pen NeedleFMI · Traditional | Ningbo Medsun Medical Co., Ltd. | 03/18/2026SE |
More from Ningbo Medsun Medical Co., Ltd.
| 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 |
| K982922 | Vacutainer Brand Blood Collection SyringeJKA · Traditional | 09/22/1998SE |
| 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 Eclipse Blood Collection Needle, Models# 368607 & 368608 cleared by the FDA?
Vacutainer Brand Eclipse Blood Collection Needle, Models# 368607 & 368608 (K982541) received a 510(k) decision of Substantially Equivalent on October 28, 1998, 99 days after the submission was received.
What is the product code of K982541?
The FDA product code is FMI – Needle, Hypodermic, Single Lumen, a Class II (moderate risk) device regulated under 21 CFR 880.5570.