510(k) Report

510(k) · Cleared

Recalled · Class II · 2016

Syrex Pre-Filled Syringe

K023740510(k) TraditionalCleared May 13, 2003187-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

Excelsior Medical Corp. · NZW Heparin, Vascular Access Flush

Cleared on May 13, 2003 after a 187-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 2 of the 4 devices in its family, counting itself, have a Class I recall. 3 later devices descend from it. It has been recalled once.

Decided
May 13, 2003
Review
187 days
Class
Class II
Product code
NZW
Recalls
1
Predicates
0

3 later devices descend from it, 3 citing it directly. 2 of the 4 devices in this family, counting this one, have a Class I recall.

Descendants, by year cleared 2009: 1 descendant cleared, 1 with a Class I recall12011: 1 descendant cleared, 1 with a Class I recall12014: 1 descendant cleared200020052010201520202025
  1. This deviceK023740 Syrex Pre-Filled SyringeExcelsior Medical Corp. · 2003
  2. Descendant · cites it directly · 1 of its ownK082689 Sterile Sodium Chloride 0.9% Flush, 5ML, 10ML, AmpuleSpectra Medical Devices, Inc. · 2009 · Recalled (Class I)
  3. Descendant · cites it directly · 0 of its ownK133446 Heparin Lock / Flush SyringesExcelsior Medical Corporation · 2014 · Recalled
  4. Descendant · cites it directly · 0 of its ownK103740 Sodium Chloride Injection, 0.9%, Usp 5 ML, 10 ML AmpuleSpectra Medical Devices, Inc. · 2011 · Recalled (Class I)

Class I recalls in this family

  • K082689 Sterile Sodium Chloride 0.9% Flush, 5ML, 10ML…cites it directly · 2009
  • K103740 Sodium Chloride Injection, 0.9%, Usp 5 ML, 10 ML…cites it directly · 2011

Most influential descendants

Showing 3 of 3 · See all
  • K082689Sterile Sodium Chloride 0.9% Flush, 5ML, 10ML, AmpuleSpectra Medical Devices, Inc. · 2009 · cites it directly1descendant
  • K133446Heparin Lock / Flush SyringesExcelsior Medical Corporation · 2014 · cites it directly0descendants
  • K103740Sodium Chloride Injection, 0.9%, Usp 5 ML, 10 ML AmpuleSpectra Medical Devices, Inc. · 2011 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K023740Syrex Pre-Filled SyringeExcelsior Medical Corp.2003—
+1K082689Sterile Sodium Chloride 0.9% Flush, 5ML, 10ML, AmpuleSpectra Medical Devices, Inc.2009Class I
+1K133446Heparin Lock / Flush SyringesExcelsior Medical Corporation20141
+1K103740Sodium Chloride Injection, 0.9%, Usp 5 ML, 10 ML AmpuleSpectra Medical Devices, Inc.2011Class I

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200911
201111
201410
FIG. 1 — Lineage of K023740, 2003–2014Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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

2 devices in this family have a Class I recall. 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?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (3)

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K082689Sterile Sodium Chloride 0.9% Flush, 5ML, 10ML, Ampule Class ISpectra Medical Devices, Inc.20091
K133446Heparin Lock / Flush SyringesExcelsior Medical Corporation20140
K103740Sodium Chloride Injection, 0.9%, Usp 5 ML, 10 ML Ampule Class ISpectra Medical Devices, Inc.20110

Has anything in its family been recalled? (2 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Apr 28, 2016Class IIZ-1989-2016Nonconforming Material/ComponentCertain lots of Heparin Lock Flush, USP Syringes (5 ml Fill in 10 ml Syringe) failed Anti-Factor IIa assay for potency during testing of retention samples for heparin potency.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K082689Sterile Sodium Chloride 0.9% Flush, 5ML, 10ML, AmpuleSpectra Medical Devices, Inc. · 2009 · Cites it directly · ◆ in the 2009 descendants bar of FIG. 11 Class I recall
  • K103740Sodium Chloride Injection, 0.9%, Usp 5 ML, 10 ML AmpuleSpectra Medical Devices, Inc. · 2011 · Cites it directly · ◆ in the 2011 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • Of its descendants, K082689 (Spectra Medical Devices, Inc., 2009) has gone furthest, with 1 descendant of its own.

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.

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?

Flushing of IV catheters and IV tubing only. Prior to andafter administration of intermittent medication, entirely flush the catheter and or tubing with Heparin Lock Flush Solution, either USP 10 UnitslmL or USP 100 Units/mL. Use in accordance with any warning or precautions appropriate to medication being administered. lbis device is not to be used for anticoagulant therapy.

Protect from freezing and avoid excessive heat. Store at 25°C (77° F); excursions permitted to 15° - 30°C (59°-86°F)

Indications for use as stated in the FDA 510(k) statement.

More from Excelsior Medical Corp.

9 FDA decisions under this applicant name. See the company

  • K130975Swabcap and SwabflushExcelsior Medical Corp. · 20132 recalls
  • K101270Swabflsuh (3ML, 5ML, 10ML) Model 10331, 10351, 10311Excelsior Medical Corp. · 2011
  • K083508SwabcapExcelsior Medical Corp. · 2009
  • K082837Sterile Field Saline Pre-Filled Syringe (S)Excelsior Medical Corp. · 20081 recall
  • K061497Syrex Heparin Lock Flush Syringe, 1 Unit/ML & 2 Units/MLExcelsior Medical Corp. · 200713 recalls

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
  • 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

https://510kreport.com/device/K023740 · printed Nov 6, 2026

Cite this page

510(k) Report. “K023740: Syrex Pre-Filled Syringe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023740

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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