# K092938: Heparin Lock Flush Solution Usp, Models 504401, 504411, 504505, 505701, 504901, 1710

- Pathway: 510(k) (Traditional)
- Applicant: App Pharmaceuticals, LLC
- Decided: Jun 18, 2010 after 267 days
- Product code: NZW (Heparin, Vascular Access Flush)
- 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
Longest line of descent: 1 generation back to K001795 (2000). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001795: The Avitro LLC, 10 and 100 Uso Units/ML Heparin Sodium Vafd, Avitro, LLC (2000) Summary page 2.

## Recalls of this device
- Dec 19, 2014 · Class II · Z-1032-2015: The lot failed pH specification.

## Indications for use
Heparin Lock Flush Solution, USP product code 505701 (10 Units/mL) and product code 504901 (100 USP Units/mL) is intended to maintain patency of an indwelling venipuncture device designed for intermittent injection or infusion therapy or blood sampling.

Source page: https://510kreport.com/device/K092938
Methodology: https://510kreport.com/methodology