# K121007: Neo Delta Self Safe T, Neo Delta Self Safe T, Neo Delta Self Safe 1, Neo Delta Self Safe 1

- Pathway: 510(k) (Traditional)
- Applicant: Delta Med Srl
- Decided: Dec 28, 2012 after 269 days
- Product code: FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days)
- Device class: 2
- Regulation: 21 CFR 880.5200
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K801941 (1980). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072419: Advantiv Safety I.V. Catheter, Smiths Medical Asd, Inc. (2007) Summary page 3.
- K982805: Introcan Safety IV Catheter, B.Braun Medical, Inc. (1999) Summary page 3.

## Recalls of this device
- Jun 21, 2021 · Class II · Z-2301-2021: Problems related to the sterilization of the medical devices; possible missing sterility of the medical device
- Jun 21, 2021 · Class II · Z-2300-2021: Problems related to the sterilization of the medical devices; possible missing sterility of the medical device
- Jun 21, 2021 · Class II · Z-2302-2021: Problems related to the sterilization of the medical devices; possible missing sterility of the medical device
- Jun 21, 2021 · Class II · Z-2303-2021: Problems related to the sterilization of the medical devices; possible missing sterility of the medical device
- Jun 21, 2021 · Class II · Z-2304-2021: Problems related to the sterilization of the medical devices; possible missing sterility of the medical device
- Jun 21, 2021 · Class II · Z-2299-2021: Problems related to the sterilization of the medical devices; possible missing sterility of the medical device

## Indications for use
Neo Delta Self Safe Catheters are intravascular catheters intended for short term use for the intravenous administration of fluids.

Source page: https://510kreport.com/device/K121007
Methodology: https://510kreport.com/methodology