# K124026: Lobster Auto-Injector

- Pathway: 510(k) (Traditional)
- Applicant: Scandinavian Health Limited
- Decided: Sep 13, 2013 after 259 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: 3 generations back to K945660 (1995). 4 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K945660: Autoject 2, Owen Mumford USA, Inc. (1995) Summary page 1.
- K013362: Autoject 2, Owen Mumford USA, Inc. (2001) Summary page 1.
- K033696: Personal Injector, Union Medico Aps (2005) Summary page 1.

## Most influential descendants
- K243232: GripMate (2024), 0 descendants of its own
- K141384: Whisperject Autoinjector (2014), 0 descendants of its own

## Indications for use
The Lobster device is intended for use with a 1 mL glass syringe, containing a fixed needle of 27 to 29 gauge, and drug product solutions with a viscosity between 1 and 4 mPa*s. The Lobster auto-injector is a reusable injection device for the subcutaneous injection of FDA approved drugs.

Source page: https://510kreport.com/device/K124026
Methodology: https://510kreport.com/methodology