510(k) · Cleared
ClearedBD PosiFlush Heparin Lock Flush Syringe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Becton, Dickinson and Company · NZW Heparin, Vascular Access Flush
Cleared on Feb 27, 2017 as substantially equivalent to K090680 (Becton, Dickinson & CO, 2009) after a 69-day review. Its family tree reaches back 4 generations to 1995.
- Decided
- Feb 27, 2017
- Review
- 69 days
- Class
- Class II
- Product code
- NZW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K952645 (1995). 8 ancestors in all, the oldest K953120 (1995). No later device cites it as a predicate yet.
- Root · 4 generations backK952645 Vital Signs Saline Vascular Access Flush DeviceVital Signs, Inc. · 1995
- 3 generations backK982558 BD Preefile Normal Saline Flush Syringe Flush SyringeBd/Preefil · 2000
- 2 generations backK011967 BD Pre-Filled Heparin Lock Flush in 0.9% Sodium Chloride Injection…Bd · 2002
- 1 generation backK090680 Heparin Lock Flush Solution, Usp BD Posiflush Heparin Lock Flush…Becton, Dickinson & CO · 2009
- This deviceK163591 BD PosiFlush Heparin Lock Flush SyringeBecton, Dickinson and Company · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K952645 | Vital Signs Saline Vascular Access Flush Device | Vital Signs, Inc. | 1995 | — |
| −3 | K982558 | BD Preefile Normal Saline Flush Syringe Flush Syringe | Bd/Preefil | 2000 | — |
| −2 | K011967 | BD Pre-Filled Heparin Lock Flush in 0.9% Sodium Chloride Injection, Usp Syringe | Bd | 2002 | — |
| −1 | K090680 | Heparin Lock Flush Solution, Usp BD Posiflush Heparin Lock Flush Syringe | Becton, Dickinson & CO | 2009 | — |
| 0 (this device) | K163591 | BD PosiFlush Heparin Lock Flush Syringe | Becton, Dickinson and Company | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 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 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K090680 | Heparin Lock Flush Solution, Usp BD Posiflush Heparin Lock Flush SyringeSummary page 4…Solution, USP- BD PosiFlush™ Heparin Lock Flush Syringe 510(k) Reference: K090680 Common Name: Heparin, Vascular Access Flush Classificatio… | 2009 |
What descends from it?
No later submission names this one as a predicate yet.
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 22 years and passes through 5 companies; a new generation was cleared every 7.4 years on median.
- 1 of the 8 ancestors has a recall of any class.
How does its category compare?
All NZW devicesNZW Heparin, Vascular Access Flush: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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?
The Heparin Lock Flush Solution, USP, BD PosiFlush™ Heparin Lock Flush Syringes are intended for maintenance of patency of vascular access devices only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K163591 · printed Nov 4, 2026
Cite this page
510(k) Report. “K163591: 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/K163591
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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