# K982541: Vacutainer Brand Eclipse Blood Collection Needle, Models# 368607 & 368608

- Pathway: 510(k) (Traditional)
- Applicant: Becton Dickinson Vacutainer Systems
- Decided: Oct 28, 1998 after 99 days
- Product code: FMI (Needle, Hypodermic, Single Lumen)
- Device class: 2
- Regulation: 21 CFR 880.5570
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K972404 (1997). 1 ancestor in all.
25 later devices descend from it; 8 cite it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972404: Vacutainer Brand Safety Blood Collection Assembly (Multiple), Bd Becton Dickinson Vacutainer Systems Preanalytic (1997) Summary page 3.
- (no number) VACUTAINER® Brand VACUTAINER® Blood Collection Needle: named in the summary without a submission number

## Most influential descendants
- K172763: Blood Collecting Needle, Safety Blood Collecting Needle, Blood Collecting Needle with Holder, Safety Blood Collecting Needle with Holder, Blood Collecting Set, Safety Blood Collecting Set, Blood Collecting Set with Holder, Safety Blood Collecting Set with Holder (2018), 13 descendants of its own
- K200027: Blood Collection Needle with/without Holder, Safety Blood Collection Needle with/without Holder, Luer Access Device-holder with Preattached Multiple Sample Adapter (2020), 6 descendants of its own
- K033478: Vacuette Quickshield Safety Tube Holder (2003), 5 descendants of its own
- K102774: Vacuette Quickshield with Snappy Tude Holder (2010), 2 descendants of its own
- K230080: Blood Collection Set, Blood Collection Set with Holder, Safety Blood Collection Set, Safety Blood Collection Set with Holder, Blood (2023), 1 descendant of its own

## Recalls of this device
- Mar 7, 2019 · Class II · Z-0252-2020: BD PAS received customer complaints indicating the absence of the bevel on the non-patient needle end of the product, causing blood leakage.

## Indications for use
The VACUTAINER® Brand ECLIPSE™ Blood Collection Needle is a sterile, multiple sample, single-use device for blood collection. The needle is designed with an attached safety shield, which can be activated to cover the needle immediately after venipuncture to provide protection from accidental needle sticks.

Source page: https://510kreport.com/device/K982541
Methodology: https://510kreport.com/methodology