# K250907: Sol-Guard TM XtraThin Safety Pull-Button Blood Collection Set

- Pathway: 510(k) (Special)
- Applicant: Sol-Millennium Medical, Inc.
- Decided: Apr 30, 2025 after 35 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 Sol- GuardTM XtraThin Wall Safety Pull button blood collection set is a sterile, multi-sample, single-use fixed winged blood collection set intended for venipuncture to obtain blood specimens from patients. When used without the male Luer adaptor, the device allows the clinician to obtain blood sampling to the female hub with a syringe, if necessary or can be used for short-term (up to 2 hours), single infusions with consideration given to patient size and appropriateness for the solution being infused. The device is not to be left in place and should remain under the direct supervision of a clinician. The recommended use of the device is to activate the needle safety feature prior to removal from the venipuncture site. The retraction of the intravenous (IV) end of the needle aids in the prevention of accidental needlestick injury.

Source page: https://510kreport.com/device/K250907
Methodology: https://510kreport.com/methodology