510(k) Report

510(k) · Cleared

Recalled · Class II · 2014

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

K092938510(k) TraditionalCleared Jun 18, 2010267-day reviewClass II21 CFR 880.5200Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

App Pharmaceuticals, LLC · NZW Heparin, Vascular Access Flush

Cleared on Jun 18, 2010 as substantially equivalent to K001795 (Avitro, LLC, 2000) after a 267-day review. Its family tree reaches back 1 generation to 2000. It has been recalled once.

Decided
Jun 18, 2010
Review
267 days
Class
Class II
Product code
NZW
Recalls
1
Predicates
1

Its longest line of descent runs back 1 generation to K001795 (2000). No later device cites it as a predicate yet.

K001795 · The Avitro LLC, 10 and 100 Uso Units/ML Heparin Sodium Vafd · Avitro, LLC · 20002000200220042006200820102012
K001795 · The Avitro LLC, 10 and 100 Uso Units/ML Heparin Sodium Vafd · Avitro, LLC · 20000
  1. Root · 1 generation backK001795 The Avitro LLC, 10 and 100 Uso Units/ML Heparin Sodium VafdAvitro, LLC · 2000
  2. This deviceK092938 Heparin Lock Flush Solution Usp, Models 504401, 504411, 504505…App Pharmaceuticals, LLC · 2010
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K001795The Avitro LLC, 10 and 100 Uso Units/ML Heparin Sodium VafdAvitro, LLC2000—
0 (this device)K092938Heparin Lock Flush Solution Usp, Models 504401, 504411, 504505, 505701…App Pharmaceuticals, LLC2010—
FIG. 1 — Lineage of K092938, 2000–2010Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in NZW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
Get a 510(k) Report

What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K001795The Avitro LLC, 10 and 100 Uso Units/ML Heparin Sodium Vafd
Summary page 2
…claims the proposed devices to be substantially equivalent to the devices previously cleared by FDA in K001 795. APP claims this equivalence because the proposed devices have an equivalent…
Avitro, LLC2000—

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Dec 19, 2014Class IIZ-1032-2015Component design/selectionThe lot failed pH specification.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has no recall.

How does its category compare?

All NZW devices

NZW Heparin, Vascular Access Flush: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.

FDA decisions per year · NZW

1in 2017

2007: 12009: 12010: 22014: 12017: 1
2007high 2 (2010) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NZW

Too few NZW 510(k)s in any year since 2007 to give a median.

Recalls per year · NZW

1in 2014

2008: 222010: 32012: 12014: 1
2007high 22 (2008) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · NZW

11in 2025

2007: 212008: 2912009: 1222010: 1942011: 332012: 92013: 152014: 82015: 52017: 32018: 192019: 192020: 32021: 102022: 142023: 92024: 102025: 11
2007high 291 (2008) · low 0 (2016)2025

MAUDE reports naming product code NZW, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—021
20080—22291
20091—0122
20102—3194
20110—033
20120—19
20130—015
20141—18
20150—05
20160—00
20171—03
20180—019
20190—019
20200—03
20210—010
20220—014
20230—09
20240—010
20250—011
20260—0—

What is it indicated for?

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.

Indications for use as stated in the FDA summary.

Recent decisions in NZW

The NZW category page

  • K163591BD PosiFlush Heparin Lock Flush SyringeBecton, Dickinson and Company · 2017
  • K133446Heparin Lock / Flush SyringesExcelsior Medical Corporation · 20141 recall
  • K092491Medefil's Heparin I.V. Flush Syringe 1 Unit/ML; 10 Units/ML; and 100 Units/ML in Various Fill SizesMedefil, Inc. · 20104 recalls
  • K090680Heparin Lock Flush Solution, Usp BD Posiflush Heparin Lock Flush SyringeBecton, Dickinson & CO · 2009
  • K061497Syrex Heparin Lock Flush Syringe, 1 Unit/ML & 2 Units/MLExcelsior Medical Corp. · 200713 recalls

https://510kreport.com/device/K092938 · printed Nov 4, 2026

Cite this page

510(k) Report. “K092938: Heparin Lock Flush Solution Usp, Models 504401, 504411, 504505, 505701, 504901, 1710.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092938

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026