# K250983: Medblue Skin Prick Test Applicator (AS103, AS108, AS109, AS110, AS111, AS113, AS132, AS134, AS146, AS148, AS160, AS162, AS170, AS172)

- Pathway: 510(k) (Traditional)
- Applicant: Asistan Medikal
- Decided: Jan 30, 2026 after 305 days
- Product code: SCL (Allergen And Vaccine Delivery Needles)
- Device class: 2
- Regulation: 21 CFR 880.5570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K961918 (1996). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182582: Oryum and Ovem Epidermal Deri Prick Test Applicator, Allergy & Applicator Depot, LLC (2019) Summary page 5.

## Indications for use
Used for percutaneous administration of diagnostic allergenic extracts.

Source page: https://510kreport.com/device/K250983
Methodology: https://510kreport.com/methodology