# K013556: Monoject Prefill Heparin Lock Flush Syringe

- Pathway: 510(k) (Traditional)
- Applicant: Tyco Healthcare
- Decided: Dec 31, 2001 after 67 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: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K003245 (2000). 1 ancestor in all.
5 later devices descend from it; 2 cite it directly.
1 of 7 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003245: Heparin Lock Flush Syring 10 Usp Units/ML, Heparin Lock Flush Syringe, 100 Usp Units/ML, Baxter Healthcare Corp (2000)

## Most influential descendants
- K032438: Modification to: Monojet Prefill 0.9% Sodium Chloride Flush Syringe, Monojet Prefill Heprin Lock Flush Syringe (2004), 2 descendants of its own
- K090680: Heparin Lock Flush Solution, Usp BD Posiflush Heparin Lock Flush Syringe (2009), 1 descendant of its own
- K163591: BD PosiFlush Heparin Lock Flush Syringe (2017), 0 descendants of its own
- K090882: Flush Syringe Filled with 0.9% Sodium Chloride (2010), 0 descendants of its own
- K060339: Kendall Monoject Pre-Fill Advanced 0.9%Sodium Chloride Flush Syringes for Sterile Delivery (2006), 0 descendants of its own

## Indications for use
The Heparin Lock Flush Syringe, 10 and 100 units/ml is intended for use in flushing compatible intravenous administration sets and indwelling intravenous access devices.

Source page: https://510kreport.com/device/K013556
Methodology: https://510kreport.com/methodology