510(k) · Cleared
Recalled · 2007Heparin Lock Flush Syringe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Am2 Pat, Inc. · FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Cleared on Dec 23, 2003 as substantially equivalent to K002142 (Emt-Rx, 2002) and 3 other predicates after a 140-day review. Its family tree reaches back 3 generations to 1995. It has been recalled once.
- Decided
- Dec 23, 2003
- Review
- 140 days
- Class
- Class II
- Product code
- FOZ
- Recalls
- 1
- Predicates
- 4
Its longest line of descent runs back 3 generations to K952645 (1995). 8 ancestors in all, the oldest K953120 (1995). No later device cites it as a predicate yet.
- Root · 3 generations backK952645 Vital Signs Saline Vascular Access Flush DeviceVital Signs, Inc. · 1995
- 2 generations backK982558 BD Preefile Normal Saline Flush Syringe Flush SyringeBd/Preefil · 2000
- 1 generation backK011967 BD Pre-Filled Heparin Lock Flush in 0.9% Sodium Chloride Injection…Bd · 2002
- This deviceK032417 Heparin Lock Flush SyringeAm2 Pat, Inc. · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K952645 | Vital Signs Saline Vascular Access Flush Device | Vital Signs, Inc. | 1995 | — |
| −2 | K982558 | BD Preefile Normal Saline Flush Syringe Flush Syringe | Bd/Preefil | 2000 | — |
| −1 | K011967 | BD Pre-Filled Heparin Lock Flush in 0.9% Sodium Chloride Injection, Usp Syringe | Bd | 2002 | — |
| 0 (this device) | K032417 | Heparin Lock Flush Syringe | Am2 Pat, Inc. | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 2000 | 2 | 0 |
| 2002 | 2 | 0 |
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 FOZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new FOZ device
- #1 K243403 BD Nexiva™ Closed IV Catheter Systemscore 14.8 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K002142 | Saline IV Flush SyringeSummary page 1…Product/Device 510k Number EMT-Rx Saline IV Flush Syringe K002142 Becton Dickinson BD PosiFl ushim Heparin Lock Flush Syringe KOI 1967 Baxter Healthcare… | 2002 |
| * | K011967 | BD Pre-Filled Heparin Lock Flush in 0.9% Sodium Chloride Injection, Usp Syringe | 2002 |
| * | K003245 | Heparin Lock Flush Syring 10 Usp Units/ML, Heparin Lock Flush Syringe, 100 Usp Units/MLSummary page 1…BD PosiFl ushim Heparin Lock Flush Syringe KOI 1967 Baxter Healthcare H-eparin Lock Flush Syringe K003245 Medefil, Inc Heparin IV Flush Syringe K020996 Device Description: The p… | 2000 |
| * | K020996 | Medefil's Heparin I.V. Flush Syringe in Various Fill Sizes - 1 ML Fill in 6 ML Syringe…Summary page 1…H-eparin Lock Flush Syringe K003245 Medefil, Inc Heparin IV Flush Syringe K020996 Device Description: The proposed device is a sterile, single use, standard piston type syringe that is available in various… | 2002 |
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
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 11, 2007 | Not classified | Z-0827-2008 | Process design | Lack of assurance of sterility by manufacturer |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 8 years and passes through 4 companies; a new generation was cleared every 1.9 years on median.
- 2 of the 8 ancestors have a recall of any class.
How does its category compare?
All FOZ devicesFOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FOZ
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FOZ
91in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FOZ
4in 2023
Class I (5 since 2007) Class II/III not classified
Adverse event reports per year · FOZ
5,110in 2025
MAUDE reports naming product code FOZ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 6 | 159 | 16 | 374 |
| 2008 | 9 | 103 | 0 | 422 |
| 2009 | 9 | 30 | 23 | 508 |
| 2010 | 3 | 28 | 115 | 370 |
| 2011 | 6 | 132 | 0 | 786 |
| 2012 | 13 | 122 | 0 | 560 |
| 2013 | 4 | 104 | 2 | 640 |
| 2014 | 9 | 99 | 4 | 815 |
| 2015 | 10 | 107 | 0 | 729 |
| 2016 | 9 | 63 | 3 (1) | 925 |
| 2017 | 9 | 51 | 22 | 1,966 |
| 2018 | 1 | — | 4 | 3,305 |
| 2019 | 8 | 140 | 3 | 4,365 |
| 2020 | 10 | 191 | 3 | 3,797 |
| 2021 | 4 | 242 | 1 | 4,674 |
| 2022 | 8 | 183 | 4 (2) | 4,133 |
| 2023 | 9 | 129 | 4 (2) | 4,430 |
| 2024 | 6 | 190 | 0 | 4,772 |
| 2025 | 11 | 91 | 0 | 5,110 |
| 2026 | 7 | 203 | 2 | — |
What is it indicated for?
The Heparin Flush Syringe, 10 and 100 units/mL is intended for use in flushing compatible intravenous administration sets and indwelling intravenous access devices.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032417 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032417: Heparin Lock Flush Syringe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032417
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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