# K943836: Pre-Filled 10CC Inflation Syringe W/Sterile Water

- Pathway: 510(k) (Traditional)
- Applicant: Orion Life Systems, Inc.
- Decided: Nov 21, 1994 after 108 days
- Product code: JOL (Catheter And Tip, Suction)
- Device class: 2
- Regulation: 21 CFR 880.6740
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 1 cites it directly.
1 of 5 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K030813: Primary Care Solutions Prefilled 10CC and Prefilled 30CC Inflation Syringes with Sterile Water Catalog Numbers 1010 and (2003), 3 descendants of its own
- K181814: AMSure Pre-filled Syringe for Balloon Inflation with Sterile Water (2018), 1 descendant of its own
- K202698: Prefilled Syringe (2020), 0 descendants of its own
- K200556: AquaFlate Pre-Filled Sterile Water Syringe 10mL (2020), 0 descendants of its own

Source page: https://510kreport.com/device/K943836
Methodology: https://510kreport.com/methodology