510(k) · Cleared
Recalled · Class II · 2022Heparin Lock / Flush Syringes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Excelsior Medical Corporation · NZW Heparin, Vascular Access Flush
Cleared on Nov 14, 2014 as substantially equivalent to K023740 (Excelsior Medical Corp., 2003) and 1 other predicate after a 367-day review. Its family tree reaches back 1 generation to 2003. It has been recalled once.
- Decided
- Nov 14, 2014
- Review
- 367 days
- Class
- Class II
- Product code
- NZW
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 1 generation to K023740 (2003). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK023740 Syrex Pre-Filled SyringeExcelsior Medical Corp. · 2003 · Recalled
- This deviceK133446 Heparin Lock / Flush SyringesExcelsior Medical Corporation · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K023740 | Syrex Pre-Filled Syringe | Excelsior Medical Corp. | 2003 | 1 |
| 0 (this device) | K133446 | Heparin Lock / Flush Syringes | Excelsior Medical Corporation | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 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 |
|---|---|---|---|
| * | K023740 | Syrex Pre-Filled SyringeSummary page 4…g devices as related to intended use, design, and material characteristics: Syrex Pre-Filled Syringe, 10 U/mL & 100 U/mL, Excelsior Medical Corporation, K023740 Syrex Heparin Lock Flush Syringe, 1 U/mL & 2 U/mL, Excelsior Medical Corporation, K061497 Description of the Dev… | 2003 |
| * | K061497 | Syrex Heparin Lock Flush Syringe, 1 Unit/ML & 2 Units/MLSummary page 4…nge, 10 U/mL & 100 U/mL, Excelsior Medical Corporation, K023740 Syrex Heparin Lock Flush Syringe, 1 U/mL & 2 U/mL, Excelsior Medical Corporation, K061497 Description of the Device Excelsior Medical’s Heparin Lock Flush, USP devices are provided as terminally sterilized, single-use… | 2007 |
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 |
|---|---|---|---|---|
| May 25, 2022 | Class II | Z-1596-2022 | Environmental control | Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- 2 of the 2 ancestors have a recall of any class.
- 2 other devices also cite its predicate K023740.
How does its category compare?
All NZW devicesNZW Heparin, Vascular Access Flush: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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?
Flushing of IV catheters and IV tubing only. Solution is intended for maintenance of patency of intravenous injection devices. Prior to and after administration of intermittent medication, entirely flush the intravenous injection device (catheter and or tubing) with Heparin Lock 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. Heparin…
Read the full statement (192 words)
Flushing of IV catheters and IV tubing only. Solution is intended for maintenance of patency of intravenous injection devices. Prior to and after administration of intermittent medication, entirely flush the intravenous injection device (catheter and or tubing) with Heparin Lock 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.
Heparin Lock Flush, USP is supplied as:
• 3 USP Units per 3 mL (1 USP unit per mL); 3 mL volume in a 10 mL syringe
• 6 USP Units per 3 mL (2 USP unit per mL); 3 mL volume in a 10 mL syringe
• 30 USP Units per 3 mL (10 USP unit per mL); 3 mL volume in a 10 mL syringe
• 50 USP Units per 5 mL (10 USP unit per mL); 5 mL volume in a 10 mL syringe
• 300 USP Units per 3 mL (100 USP unit per mL); 3 mL volume in a 10 mL syringe
• 500 USP Units per 5 mL (100 USP unit per mL); 5 mL volume in a 10 mL syringe
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133446 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133446: Heparin Lock / Flush Syringes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133446
Report an extraction error
Are you the manufacturer?
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