510(k) Report

FDA product code · General hospital

Heparin, Vascular Access Flush

NZWClass II21 CFR 880.5200510(k) required7 decisions since 200327 recalls

7 FDA decisions since 2003. 27 recalls name this code, 0 of them Class I. The most-cited predicate is K023740, named by 3 later devices.

Enhance the performance of intravascular catheters, to maintain patency of the vascular catheter when it is not in use.

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

FIG. A — Illustration, general hospital panel

Twenty years of NZW at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

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—
FIG. 1 — NZW by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in NZW? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which predicates do NZW devices cite most?

Devices in this code that later submissions most often claim equivalence to.

  • K023740Syrex Pre-Filled SyringeExcelsior Medical Corp. · 20033cite it
  • K061497Syrex Heparin Lock Flush Syringe, 1 Unit/ML & 2 Units/MLExcelsior Medical Corp. · 20071cites it
  • K090680Heparin Lock Flush Solution, Usp BD Posiflush Heparin Lock Flush SyringeBecton, Dickinson & CO · 20091cites it

Which NZW devices have the deepest lineage?

Devices in this code with the longest line of descent behind them.

  • K163591BD PosiFlush Heparin Lock Flush SyringeBecton, Dickinson and Company · 20174generations
  • K090680Heparin Lock Flush Solution, Usp BD Posiflush Heparin Lock Flush SyringeBecton, Dickinson & CO · 20093generations
  • K092491Medefil's Heparin I.V. Flush Syringe 1 Unit/ML; 10 Units/ML; and 100 Units/ML in Various Fill SizesMedefil, Inc. · 20102generations
  • K133446Heparin Lock / Flush SyringesExcelsior Medical Corporation · 20141generation
  • K092938Heparin Lock Flush Solution Usp, Models 504401, 504411, 504505, 505701, 504901, 1710App Pharmaceuticals, LLC · 20101generation

What has FDA decided in NZW lately?

  • K163591BD PosiFlush Heparin Lock Flush SyringeBecton, Dickinson and Company · 2017
  • K133446Heparin Lock / Flush SyringesExcelsior Medical Corporation · 20141 recall
  • K092938Heparin Lock Flush Solution Usp, Models 504401, 504411, 504505, 505701, 504901, 1710App Pharmaceuticals, LLC · 20101 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

All 7 NZW decisions →

What has been recalled in NZW lately?

  • K092938HEPFLUSH-10 (HEPARIN LOCK FLUSH SOLUTION, USP) 100 USP units per 10 mL (10 USP units per…Fresenius Kabi USA, LLC · Dec 19, 2014Class II
  • K061497Heparin Lock Flush Solution 100 Unit/mL, USP 3 ml, 4 ml, 5mL, 6 ml fill in a 10 ml Flush…Excelsior Medical Corp · May 7, 2012
  • K092491Medefil Heparin I.V. Flush Syringe 100 units/mL; a polypropylene luer locking syringe…Medefil Incorporated · Nov 1, 2010
  • K092491Medefil Heparin I.V. Flush Syringe 10 units/mL; a polypropylene luer locking syringe…Medefil Incorporated · Nov 1, 2010
  • K092491Medefil Heparin I.V. Flush Syringe 1 units/mL; a polypropylene luer locking syringe…Medefil Incorporated · Nov 1, 2010
  • K032438Tyco HealthcareMonoject Prefill 10U/mL Heparin Lock Flush Syringe, 3mL REF # 8881580123…Covidien LP · Mar 28, 2008

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Other codes under 21 CFR 880.5200.

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