510(k) · Cleared
Recalled · Class II · 2012Syrex Heparin Lock Flush Syringe, 1 Unit/ML & 2 Units/ML
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Excelsior Medical Corp. · NZW Heparin, Vascular Access Flush
Cleared on Feb 23, 2007 after a 268-day review. The FDA summary names its predicate without a number. 1 later device descends from it. It has been recalled 13 times.
- Decided
- Feb 23, 2007
- Review
- 268 days
- Class
- Class II
- Product code
- NZW
- Recalls
- 13
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK061497 Syrex Heparin Lock Flush Syringe, 1 Unit/ML & 2 Units/MLExcelsior Medical Corp. · 2007
- Descendant · cites it directly · 0 of its ownK133446 Heparin Lock / Flush SyringesExcelsior Medical Corporation · 2014 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K133446Heparin Lock / Flush SyringesExcelsior Medical Corporation · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K061497 | Syrex Heparin Lock Flush Syringe, 1 Unit/ML & 2 Units/ML | Excelsior Medical Corp. | 2007 | — |
| +1 | K133446 | Heparin Lock / Flush Syringes | Excelsior Medical Corporation | 2014 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 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 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
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | — | Medefil 1 U/ml Flush Syringe Named without a submission number | |
| * | — | Hospital pharmacy filled 1 U/ml Flush Syringe Named without a submission number |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K133446 | Heparin Lock / Flush Syringes | 2014 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 11, 2012 | Class II | Z-1799-2012 | Nonconforming Material/Component | Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringes therefore Vygon has subsequently initiated a recall on Vygon branded Heparin Lock Flush Syringes and kits containing the syringes. |
| May 11, 2012 | Class II | Z-1808-2012 | Nonconforming Material/Component | Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringes therefore Vygon has subsequently initiated a recall on Vygon branded Heparin Lock Flush Syringes and kits containing the syringes. |
| May 11, 2012 | Class II | Z-1803-2012 | Nonconforming Material/Component | Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringes therefore Vygon has subsequently initiated a recall on Vygon branded Heparin Lock Flush Syringes and kits containing the syringes. |
| May 11, 2012 | Class II | Z-1801-2012 | Nonconforming Material/Component | Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringes therefore Vygon has subsequently initiated a recall on Vygon branded Heparin Lock Flush Syringes and kits containing the syringes. |
| May 11, 2012 | Class II | Z-1802-2012 | Nonconforming Material/Component | Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringes therefore Vygon has subsequently initiated a recall on Vygon branded Heparin Lock Flush Syringes and kits containing the syringes. |
| May 11, 2012 | Class II | Z-1797-2012 | Nonconforming Material/Component | Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringes therefore Vygon has subsequently initiated a recall on Vygon branded Heparin Lock Flush Syringes and kits containing the syringes. |
| May 11, 2012 | Class II | Z-1798-2012 | Nonconforming Material/Component | Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringes therefore Vygon has subsequently initiated a recall on Vygon branded Heparin Lock Flush Syringes and kits containing the syringes. |
| May 11, 2012 | Class II | Z-1807-2012 | Nonconforming Material/Component | Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringes therefore Vygon has subsequently initiated a recall on Vygon branded Heparin Lock Flush Syringes and kits containing the syringes. |
| May 11, 2012 | Class II | Z-1806-2012 | Nonconforming Material/Component | Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringes therefore Vygon has subsequently initiated a recall on Vygon branded Heparin Lock Flush Syringes and kits containing the syringes. |
| May 11, 2012 | Class II | Z-1804-2012 | Nonconforming Material/Component | Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringes therefore Vygon has subsequently initiated a recall on Vygon branded Heparin Lock Flush Syringes and kits containing the syringes. |
| May 11, 2012 | Class II | Z-1805-2012 | Nonconforming Material/Component | Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringes therefore Vygon has subsequently initiated a recall on Vygon branded Heparin Lock Flush Syringes and kits containing the syringes. |
| May 11, 2012 | Class II | Z-1800-2012 | Nonconforming Material/Component | Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringes therefore Vygon has subsequently initiated a recall on Vygon branded Heparin Lock Flush Syringes and kits containing the syringes. |
| May 7, 2012 | Not classified | Z-1707-2012 | Nonconforming Material/Component | Some lots of Heparin Lock Flush, USP Syringes (3 mL fill in 10 ml syringe, 4 mL fill in 10 ml syringe, 5 mL fill in 10 ml and 6 ml in 10 ml syringe), failed Anti-Factor IIa assay for potency. |
The 5 latest of 13 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K133446 (Excelsior Medical Corporation, 2014) has gone furthest, with 0 descendants of its own.
How does its category compare?
All NZW devicesNZW Heparin, Vascular Access Flush: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · NZW
1in 2017
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
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NZW
11in 2025
MAUDE reports naming product code NZW, 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 | 1 | — | 0 | 21 |
| 2008 | 0 | — | 22 | 291 |
| 2009 | 1 | — | 0 | 122 |
| 2010 | 2 | — | 3 | 194 |
| 2011 | 0 | — | 0 | 33 |
| 2012 | 0 | — | 1 | 9 |
| 2013 | 0 | — | 0 | 15 |
| 2014 | 1 | — | 1 | 8 |
| 2015 | 0 | — | 0 | 5 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 3 |
| 2018 | 0 | — | 0 | 19 |
| 2019 | 0 | — | 0 | 19 |
| 2020 | 0 | — | 0 | 3 |
| 2021 | 0 | — | 0 | 10 |
| 2022 | 0 | — | 0 | 14 |
| 2023 | 0 | — | 0 | 9 |
| 2024 | 0 | — | 0 | 10 |
| 2025 | 0 | — | 0 | 11 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Excelsior Medical Heparin Lock Flush Syringes (1Unit/ml and 2 Units/ml) are indicated for use in maintaining patency of vascular access devices designed for intermittent or infusion therapy. Prior to and after administration of intermittent medication, entirely flush the vascular access device with Heparin Lock Flush Solution, USP. Use in accordance with any warnings or precautions appropriate to medication being administered. This device is not to be used for anticoagulant therapy
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061497 · printed Nov 4, 2026
Cite this page
510(k) Report. “K061497: Syrex Heparin Lock Flush Syringe, 1 Unit/ML & 2 Units/ML.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061497
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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