510(k) · Cleared
ClearedVital Signs Saline Vascular Access Flush Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vital Signs, Inc. · FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Cleared on Dec 13, 1995 after a 187-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 7 later devices descend from it.
- Decided
- Dec 13, 1995
- Review
- 187 days
- Class
- Class II
- Product code
- FOZ
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 2 citing it directly.
- This deviceK952645 Vital Signs Saline Vascular Access Flush DeviceVital Signs, Inc. · 1995
- Descendant · cites it directly · 5 of its ownK982558 BD Preefile Normal Saline Flush Syringe Flush SyringeBd/Preefil · 2000
- Descendant · 2 generations on · 3 of its ownK011967 BD Pre-Filled Heparin Lock Flush in 0.9% Sodium Chloride Injection…Bd · 2002
- Descendant · 3 generations on · 1 of its ownK090680 Heparin Lock Flush Solution, Usp BD Posiflush Heparin Lock Flush…Becton, Dickinson & CO · 2009
- Descendant · 4 generations on · 0 of its ownK163591 BD PosiFlush Heparin Lock Flush SyringeBecton, Dickinson and Company · 2017
- Descendant · 3 generations on · 0 of its ownK032417 Heparin Lock Flush SyringeAm2 Pat, Inc. · 2003 · Recalled
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K982558BD Preefile Normal Saline Flush Syringe Flush SyringeBd/Preefil · 2000 · cites it directly5descendants
- K011967BD Pre-Filled Heparin Lock Flush in 0.9% Sodium Chloride Injection, Usp SyringeBd · 2002 · 2 generations on3descendants
- K090680Heparin Lock Flush Solution, Usp BD Posiflush Heparin Lock Flush SyringeBecton, Dickinson & CO · 2009 · 3 generations on1descendant
- K163591BD PosiFlush Heparin Lock Flush SyringeBecton, Dickinson and Company · 2017 · 4 generations on0descendants
- K032417Heparin Lock Flush SyringeAm2 Pat, Inc. · 2003 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K952645 | Vital Signs Saline Vascular Access Flush Device | Vital Signs, Inc. | 1995 | — |
| +1 | 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 | — |
| +3 | K090680 | Heparin Lock Flush Solution, Usp BD Posiflush Heparin Lock Flush Syringe | Becton, Dickinson & CO | 2009 | — |
| +4 | K163591 | BD PosiFlush Heparin Lock Flush Syringe | Becton, Dickinson and Company | 2017 | — |
| +3 | K032417 | Heparin Lock Flush Syringe | Am2 Pat, Inc. | 2003 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2009 | 1 | 0 |
| 2017 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (7)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K982558 (Bd/Preefil, 2000) has gone furthest, with 5 descendants of its own.
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 | — |
https://510kreport.com/device/K952645 · printed Nov 4, 2026
Cite this page
510(k) Report. “K952645: Vital Signs Saline Vascular Access Flush Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K952645
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026