# K053120: Sterile Field Saline and Heparin Lock Flush Syringes

- Pathway: 510(k) (Special)
- Applicant: Excelsior Medical Corp.
- Decided: Dec 9, 2005 after 32 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.
10 later devices descend from it; 1 cites it directly.
1 of 11 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Excelsior Saline Flush Syringes and Heparin Lock Flush Syringes: named in the summary without a submission number

## Most influential descendants
- K082837: Sterile Field Saline Pre-Filled Syringe (S) (2008), 9 descendants of its own
- K171109: Praxiject 0.9% NaCl (2017), 6 descendants of its own
- K192414: Praxiject 0.9% NaCl (2020), 3 descendants of its own
- K231754: Praxiject™ 0.9% NaCl (2023), 1 descendant of its own
- K201286: 0.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery, 1 syringe/pouch, 0.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery, 2 syringes/pouch (2020), 1 descendant of its own

## Recalls of this device
- Jan 13, 2009 · Not classified · Z-0973-2009: Sterility Issue: There is the possibility that the affected lots have pouches that were not sealed properly and could potentially compromise the external sterility of the syringes.

## Indications for use
Excelsior Sterile Field Saline Flush Syringes and Heparin Lock Flush Syringes are indicated for use in flushing IV catheters and IVtubing.

Source page: https://510kreport.com/device/K053120
Methodology: https://510kreport.com/methodology