510(k) Report

510(k) · Cleared

Recalled · Class III · 2014

Medefil's Heparin I.V. Flush Syringe 1 Unit/ML; 10 Units/ML; and 100 Units/ML in Various Fill Sizes

K092491510(k) TraditionalCleared Feb 3, 2010174-day reviewClass II21 CFR 880.5200Recalls 4

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

Medefil, Inc. · NZW Heparin, Vascular Access Flush

Cleared on Feb 3, 2010 as substantially equivalent to K020996 (Medefil, Inc., 2002) after a 174-day review. Its family tree reaches back 2 generations to 2000. It has been recalled 4 times.

Decided
Feb 3, 2010
Review
174 days
Class
Class II
Product code
NZW
Recalls
4
Predicates
1

Its longest line of descent runs back 2 generations to K993518 (2000). No later device cites it as a predicate yet.

K993518 · Medefil's Heparin I.V. Flush Syringe, in Various Fill Sizes - 1 ML Fill in 3 ML Syringe LL; 1 ML Fill in 6 ML Syringe LL · Medefil, Inc. · 2000K020996 · Medefil's Heparin I.V. Flush Syringe in Various Fill Sizes - 1 ML Fill in 6 ML Syringe LL; 2 ML Fill in 6 ML Syringe LL · Medefil, Inc. · 20022000200220042006200820102012
K020996 · Medefil's Heparin I.V. Flush Syringe in Various Fill Sizes - 1 ML Fill in 6 ML Syringe LL; 2 ML Fill in 6 ML Syringe LL · Medefil, Inc. · 2002K993518 · Medefil's Heparin I.V. Flush Syringe, in Various Fill Sizes - 1 ML Fill in 3 ML Syringe LL; 1 ML Fill in 6 ML Syringe LL · Medefil, Inc. · 20000
  1. Root · 2 generations backK993518 Medefil's Heparin I.V. Flush Syringe, in Various Fill Sizes - 1 ML…Medefil, Inc. · 2000
  2. 1 generation backK020996 Medefil's Heparin I.V. Flush Syringe in Various Fill Sizes - 1 ML…Medefil, Inc. · 2002
  3. This deviceK092491 Medefil's Heparin I.V. Flush Syringe 1 Unit/ML; 10 Units/ML; and 100…Medefil, Inc. · 2010
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K993518Medefil's Heparin I.V. Flush Syringe, in Various Fill Sizes - 1 ML Fill in 3…Medefil, Inc.2000—
−1K020996Medefil's Heparin I.V. Flush Syringe in Various Fill Sizes - 1 ML Fill in 6 ML…Medefil, Inc.2002—
0 (this device)K092491Medefil's Heparin I.V. Flush Syringe 1 Unit/ML; 10 Units/ML; and 100 Units/ML…Medefil, Inc.2010—
FIG. 1 — Lineage of K092491, 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
*K020996Medefil's Heparin I.V. Flush Syringe in Various Fill Sizes - 1 ML Fill in 6 ML Syringe…
Summary page 2
…Medefil, Inc. Heparin I. V. Flush Syringe (K020996) 10. Device Description: The Heparin 1. V. Flush Syringe (the DEVICE) is a single dose, disposable, steri…
Medefil, Inc.2002—

Also cleared against K020996: 1 other device →

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
Feb 19, 2014Class IIIZ-1149-2014Labeling Change ControlThe bar code that is printed on the Master Carton label does not correspond to the product code fully displayed on the Master Carton label. The non-matching information can only be detected by using a bar code reader. The defective bar…
Nov 1, 2010Not classifiedZ-0599-2011Material/Component ContaminationThe heparin lock flush solution was manufactured with contaminated Heparin Sodium USP Active Pharmaceutical Ingredient (API).
Nov 1, 2010Not classifiedZ-0600-2011Material/Component ContaminationThe heparin lock flush solution was manufactured with contaminated Heparin Sodium USP Active Pharmaceutical Ingredient (API).
Nov 1, 2010Not classifiedZ-0601-2011Material/Component ContaminationThe heparin lock flush solution was manufactured with contaminated Heparin Sodium USP Active Pharmaceutical Ingredient (API).

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 10 years and passes through 1 company; a new generation was cleared every 7.6 years on median.
  • None of the 2 ancestors has a recall.
  • 1 other device also cites its predicate K020996.

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?

FOR USE TO MAINTAIN THE PATENCY OF IN-DWELLING

INTRAVENOUS VASCULAR ACCESS DEVICES (IVAD)

Indications for use as stated in the FDA summary.

Also cleared against K020996

1 other device cites the same predicate.

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

More from Medefil, Inc.

7 FDA decisions under this applicant name. See the company

  • K121262Medeflush Normal Saline I.V. Flush Syringe-Sterile Field ReadyMedefil, Inc. · 2012
  • K091583Medefil's Normal Saline I.V. Flush SyringeMedefil, Inc. · 20101 recall
  • K020996Medefil's Heparin I.V. Flush Syringe in Various Fill Sizes - 1 ML Fill in 6 ML Syringe LL; 2 ML Fill in 6 ML…Medefil, Inc. · 2002
  • K020999Medefil's Normal Saline Flush Syringe in Various Fill Sizes - 1 ML Fill in 6 ML Syringe LL; 2 ML Fill in 6…Medefil, Inc. · 2002
  • K993518Medefil's Heparin I.V. Flush Syringe, in Various Fill Sizes - 1 ML Fill in 3 ML Syringe LL; 1 ML Fill in 6…Medefil, Inc. · 2000

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
  • 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/K092491 · printed Nov 4, 2026

Cite this page

510(k) Report. “K092491: Medefil's Heparin I.V. Flush Syringe 1 Unit/ML; 10 Units/ML; and 100 Units/ML in Various Fill Sizes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092491

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