# K151777: Intradermal Adapter

- Pathway: 510(k) (Traditional)
- Applicant: West Pharmaceutical Services, Inc.
- Decided: Sep 29, 2015 after 90 days
- Product code: FMF (Syringe, Piston)
- Device class: 2
- Regulation: 21 CFR 880.5860
- 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 K941657 (1994). 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)
- K123588: Intradermal Adapter, West Pharmaceutical Services, Inc. (2013) Summary page 4.

## Indications for use
The Intradermal Adapter is an accessary to a 1ml, ½ inch fixed-needle allergy syringe indicated for use on patients ranging from children 2 year to adults, as a guide for performing intradermal injections.

Source page: https://510kreport.com/device/K151777
Methodology: https://510kreport.com/methodology