# K123588: Intradermal Adapter

- Pathway: 510(k) (Traditional)
- Applicant: West Pharmaceutical Services, Inc.
- Decided: Feb 19, 2013 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: 1 generation back to K941657 (1994). 1 ancestor in all.
3 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K941657: BD Micro Fine, Ultra Fine, and Allergy Syringe, Bd Becton Dickinson Vacutainer Systems Preanalytic (1994) Summary page 1.

## Most influential descendants
- K181369: Immucise Intradermal Injection System (2018), 1 descendant of its own
- K190427: Immucise (2019), 0 descendants of its own
- K151777: Intradermal Adapter (2015), 0 descendants of its own

## Indications for use
The Intradermal Adapter is an accessory to a I ml, /2 inch fixed-needle allergy syringe indicated for use as a guide for performing intradermal injections.

Source page: https://510kreport.com/device/K123588
Methodology: https://510kreport.com/methodology