# K162917: Allerhope Allergy Skin Tester

- Pathway: 510(k) (Traditional)
- Applicant: Procare Industrial Co., Limited
- Decided: Aug 17, 2017 after 303 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: 1 generation back to K961918 (1996). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961918: Multi-Test II, Lincoln Diagnostics, Inc. (1996) Summary page 5.

## Indications for use
The Allerhope® Allergy Skin Tester is for the percutaneous administration of diagnostic allergenic extracts.

Source page: https://510kreport.com/device/K162917
Methodology: https://510kreport.com/methodology