# K003245: Heparin Lock Flush Syring 10 Usp Units/ML, Heparin Lock Flush Syringe, 100 Usp Units/ML

- Pathway: 510(k) (Special)
- Applicant: Baxter Healthcare Corp
- Decided: Dec 4, 2000 after 48 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: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
8 later devices descend from it; 3 cite it directly.
1 of 9 devices in its family (counting itself) has 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
- K013556: Monoject Prefill Heparin Lock Flush Syringe (2001), 5 descendants of its own
- K011967: BD Pre-Filled Heparin Lock Flush in 0.9% Sodium Chloride Injection, Usp Syringe (2002), 3 descendants of its own
- 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

## Recalls of this device
- Dec 12, 2002 · Not classified · Z-0457-03: Sterility questioned
- Dec 12, 2002 · Not classified · Z-0458-03: Sterility questioned

Source page: https://510kreport.com/device/K003245
Methodology: https://510kreport.com/methodology