# K852444: Asik 'Once' Syringe

- Pathway: 510(k) (Traditional)
- Applicant: Pharma-Plast USA, Inc.
- Decided: Oct 16, 1985 after 128 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
No predicates in its family tree.
11 later devices descend from it; 1 cites it directly.
2 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K022212: Portex Percutaneous Dilatational Tracheostomy Kits (2003), 10 descendants of its own
- K040014: Percutaneous Dilation Tracheostomy Kit with Single Stage Dilator and Soft Introducers for Sizes 7, 8 and 9MM Tubes Only (2004), 6 descendants of its own
- K041348: Portex Ultraperc Percutaneous Dilation Tracheostomy Kit_with Serial Dilators or Single Stage Dilator, Blue Line Ultra (2004), 5 descendants of its own
- K133597: Ciaglia Percutaneous Tracheostomy Introducer Set/Tray, Ciaglia Blue Rhino Percutaneous Tracheostomy Introducer Set/Tray (2014), 2 descendants of its own
- K041044: Ciaglia Cheetah Percutaneous Tracheostomy Introducer Set (2004), 2 descendants of its own

Source page: https://510kreport.com/device/K852444
Methodology: https://510kreport.com/methodology