# K962938: Excelsior Disposable Syringe W/Normal Saline (.9% Sodium Chloride)

- Pathway: 510(k) (Traditional)
- Applicant: Excelsior Medical Corp.
- Decided: Oct 25, 1996 after 88 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: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have 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
- K142620: 0.9% Sodium Chloride Injection, USP - 2.5 mL in 3 mL Syringe, 0.9% Sodium Chloride Injection, USP-3mL in 10 mL Syringe, 0.9% Sodium Chloride Injection, USP - 5 mL in 10 mL Syringe, 0.9% Sodium Chloride Injection, USP - 10 mL in 10 mL Syringe (2014), 0 descendants of its own
- K101270: Swabflsuh (3ML, 5ML, 10ML) Model 10331, 10351, 10311 (2011), 0 descendants of its own

## Recalls of this device
- Sep 2, 2010 · Not classified · Z-0035-2011: There is the potential for a dimensional issue in 6 ml syringe products, codes E0100-50, 10056-1000, 10056-240, 14056-240, 910056-1000, S5, to cause leakage and.or loss of sterility

Source page: https://510kreport.com/device/K962938
Methodology: https://510kreport.com/methodology