# K182582: Oryum and Ovem Epidermal Deri Prick Test Applicator

- Pathway: 510(k) (Traditional)
- Applicant: Allergy & Applicator Depot, LLC
- Decided: Apr 10, 2019 after 203 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.
1 later device descends from it; 1 cites it directly.
0 of 3 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.

## Most influential descendants
- K250983: Medblue Skin Prick Test Applicator (AS103, AS108, AS109, AS110, AS111, AS113, AS132, AS134, AS146, AS148, AS160, AS162, AS170, AS172) (2026), 0 descendants of its own

## Indications for use
Oryum and Ovem Epidermal Skin Prick Test Applicator is used for the percutaneous administration of diagnostic allergenic extracts.

Source page: https://510kreport.com/device/K182582
Methodology: https://510kreport.com/methodology