# K232308: Monarch Blood Collection Set

- Pathway: 510(k) (Traditional)
- Applicant: The Monarch Company
- Decided: Dec 4, 2023 after 124 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: 7 generations back to K970259 (1997). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213718: SOL-GUARD Safety Pull Button Collection Set, Sol-Millennium Medical, Inc. (2022) Summary page 5.

## Indications for use
The Monarch Safety Blood Collection Set is a sterile, multi-sample, single use fixed winged blood collection set. The device is indicated for general medical use in Healthcare Facilities by medical professionals with the patient population to include both adolescent and adult patients. The Monarch Blood Collection Set is intended to be used with evacuated blood collection tubes and/or blood culture bottles. The Monarch Blood Collection device is to remain under direct supervision of a medical professional during use. The Monarch Blood Collection set includes a safety feature to prevent accidental needlestick injury during normal handling and disposal. The safety feature is initiated by full manual retraction of the needle from the venipuncture site to prevent accidental needlesticks during handling and disposal. The Monarch Blood Collection set is not intended for infusion, IV administration, or transfusion.

Source page: https://510kreport.com/device/K232308
Methodology: https://510kreport.com/methodology