# K213690: Eclipse Blood Collection Set

- Pathway: 510(k) (Traditional)
- Applicant: Eclipse Medcorp, LLC
- Decided: Oct 26, 2022 after 337 days
- Product code: JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection)
- Device class: 2
- Regulation: 21 CFR 862.1675
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K931367 (1993). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200027: Blood Collection Needle with/without Holder, Safety Blood Collection Needle with/without Holder, Luer Access Device-holder with Preattached Multiple Sample Adapter, Jiangsu Caina Medical Co.,Ltd (2020) Summary page 4.

## Indications for use
The Eclipse Blood Collection Set with holder is intended to be used with vacuum blood collection tube for the collection of venous blood. The safety shield is intended to aid in the protection against accidental needle stick injury.

Source page: https://510kreport.com/device/K213690
Methodology: https://510kreport.com/methodology