510(k) Report

510(k) · Cleared

Cleared

Heparin Lock Flush Solution, Usp BD Posiflush Heparin Lock Flush Syringe

K090680510(k) SpecialCleared Jun 10, 200986-day reviewClass II21 CFR 880.5200

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

Becton, Dickinson & CO · NZW Heparin, Vascular Access Flush

Cleared on Jun 10, 2009 as substantially equivalent to K011967 (Bd, 2002) and 2 other predicates after an 86-day review. Its family tree reaches back 3 generations to 1995. 1 later device descends from it.

Decided
Jun 10, 2009
Review
86 days
Class
Class II
Product code
NZW
Recalls
None
Predicates
3

Its longest line of descent runs back 3 generations to K952645 (1995). 7 ancestors in all, the oldest K953120 (1995). 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2001: 2 other ancestors2000: 1 other ancestor1995: 1 other ancestor2017: 1 descendant clearedK952645 · Vital Signs Saline Vascular Access Flush Device · Vital Signs, Inc. · 1995K982558 · BD Preefile Normal Saline Flush Syringe Flush Syringe · Bd/Preefil · 2000K011967 · BD Pre-Filled Heparin Lock Flush in 0.9% Sodium Chloride Injection, Usp Syringe · Bd · 20021995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors2 generations back: 2 other ancestors 1 generation forward: 1 descendant K011967 · BD Pre-Filled Heparin Lock Flush in 0.9% Sodium Chloride Injection, Usp Syringe · Bd · 2002K982558 · BD Preefile Normal Saline Flush Syringe Flush Syringe · Bd/Preefil · 2000K952645 · Vital Signs Saline Vascular Access Flush Device · Vital Signs, Inc. · 19950
  1. Root · 3 generations backK952645 Vital Signs Saline Vascular Access Flush DeviceVital Signs, Inc. · 1995
  2. 2 generations backK982558 BD Preefile Normal Saline Flush Syringe Flush SyringeBd/Preefil · 2000
  3. 1 generation backK011967 BD Pre-Filled Heparin Lock Flush in 0.9% Sodium Chloride Injection…Bd · 2002
  4. This deviceK090680 Heparin Lock Flush Solution, Usp BD Posiflush Heparin Lock Flush…Becton, Dickinson & CO · 2009
  5. Descendant · cites it directly · 0 of its ownK163591 BD PosiFlush Heparin Lock Flush SyringeBecton, Dickinson and Company · 2017

Most influential descendants

Showing 1 of 1 · See all
  • K163591BD PosiFlush Heparin Lock Flush SyringeBecton, Dickinson and Company · 2017 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K952645Vital Signs Saline Vascular Access Flush DeviceVital Signs, Inc.1995—
−2K982558BD Preefile Normal Saline Flush Syringe Flush SyringeBd/Preefil2000—
−1K011967BD Pre-Filled Heparin Lock Flush in 0.9% Sodium Chloride Injection, Usp SyringeBd2002—
0 (this device)K090680Heparin Lock Flush Solution, Usp BD Posiflush Heparin Lock Flush SyringeBecton, Dickinson & CO2009—
+1K163591BD PosiFlush Heparin Lock Flush SyringeBecton, Dickinson and Company2017—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199510
200010
200120

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201710
FIG. 1 — Lineage of K090680, 1995–2017Source: 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 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
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What was it cleared against? (3)

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
*K011967BD Pre-Filled Heparin Lock Flush in 0.9% Sodium Chloride Injection, Usp SyringeBd2002—
*K0035530.9% Sodium Chloride Injection, Usp BD Pre-Filled Flush Syringe
Summary page 1
…Injection, USP - BD Pre-Filled Flush Syringe Manufacturer: Becton, Dickinson and Company 510O(k) Number:. K003553 Trade Name: Monoject Prefill Heparin Lock Flush Syringe Manufacturer: Tyco Healthcare 510O(…
Bd Becton Dickinson Vacutainer Systems Preanalytic2001—
*K013556Monoject Prefill Heparin Lock Flush Syringe
Summary page 1
…mber:. K003553 Trade Name: Monoject Prefill Heparin Lock Flush Syringe Manufacturer: Tyco Healthcare 510O(k) Number: K013556 4. -Device Description:. The Modified Device, the subj ect of this 510O(k), the Heparin Lock Flush Solution, USP -…
Tyco Healthcare2001—

Also cleared against K011967: 1 other device →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K163591BD PosiFlush Heparin Lock Flush SyringeBecton, Dickinson and Company20170

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

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 14 years and passes through 4 companies; a new generation was cleared every 4.2 years on median.
  • 1 of the 7 ancestors has a recall of any class.
  • Of its descendants, K163591 (Becton, Dickinson and Company, 2017) has gone furthest, with 0 descendants of its own.
  • 1 other device also cites its predicate K011967.

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. 2009, 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?

The Heparin Lock Flush Solution, USP, BD PosiFlush TM Heparin Lock Flush Syringes are intended for use in maintaining the patency of vascular access devices (VAD's) 10 usp units/niL and 100 usp units/mL in 3ml fill in 3ml syringe with 10ml diameter and 5ml fill in 5ml syringe with 1Oml diameter

Indications for use as stated in the FDA summary.

Also cleared against K011967

1 other device cites the same predicate.

  • K032417Heparin Lock Flush SyringeAm2 Pat, Inc. · 20031 recall

More from Becton, Dickinson & CO

190 FDA decisions under this applicant name. See the company

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  • K141474Becton Dickinson Intelliport SystemBecton, Dickinson & CO · 20141 recall
  • K140446BD Probetec Chlamydia Trachomatis (CT) QX Amplified Dna AssayBecton, Dickinson & CO · 2014
  • K140448BD Probetec Neisseria Gonorrhoeae (GC) QX Amplified Dna AssayBecton, Dickinson & CO · 2014

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
  • K061497Syrex Heparin Lock Flush Syringe, 1 Unit/ML & 2 Units/MLExcelsior Medical Corp. · 200713 recalls

https://510kreport.com/device/K090680 · printed Nov 4, 2026

Cite this page

510(k) Report. “K090680: Heparin Lock Flush Solution, Usp BD Posiflush Heparin Lock Flush Syringe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K090680

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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