# K141384: Whisperject Autoinjector

- Pathway: 510(k) (Abbreviated)
- Applicant: Scandinavian Health Limited
- Decided: Sep 12, 2014 after 108 days
- Product code: KZH (Introducer, Syringe Needle)
- Device class: 2
- Regulation: 21 CFR 880.6920
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K945660 (1995). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K124026: Lobster Auto-Injector, Scandinavian Health Limited (2013) Summary page 4.
- K945660: Autoject 2, Owen Mumford USA, Inc. (1995) Summary page 4.
- K013362: Autoject 2, Owen Mumford USA, Inc. (2001) Summary page 4.

## Indications for use
The WhisperJECT autoinjector is a non-sterile injection device. It is intended to be used with FDA approved drug products with non-viscous (aqueous) liquid formulations, which are presented in a BD 1.0 mL pre-filled glass syringe with staked needles. It is a reusable injection device for the subcutaneous injection of FDA approved drugs.

Source page: https://510kreport.com/device/K141384
Methodology: https://510kreport.com/methodology