# K131963: Tautona Injector Device

- Pathway: 510(k) (Traditional)
- Applicant: Tautona Group, LLC
- Decided: Oct 22, 2013 after 117 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: 3 generations back to K820164 (1982). 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)
- K083583: Xpresse Injection System, Nordson Efd (2009) Summary page 1.
- K050797: Tissu-Trans, Shippert Medical Technologies Corp. (2005) Summary page 1.

## Indications for use
The TauTona Injector Device is a syringe assist device and is intended for use in the administration of sterile materials/ autologous adipose tissue under aseptic conditions in accordance with the best judgment of the clinician. The TauTona Injector Device is intended for use with standard syringes and cannula.

Source page: https://510kreport.com/device/K131963
Methodology: https://510kreport.com/methodology