510(k) · Cleared
ClearedBD Preefile Normal Saline Flush Syringe Flush Syringe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bd/Preefil · FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Cleared on Mar 8, 2000 as substantially equivalent to K952645 (Vital Signs, Inc., 1995) after a 595-day review. Its family tree reaches back 1 generation to 1995. 5 later devices descend from it.
- Decided
- Mar 8, 2000
- Review
- 595 days
- Class
- Class II
- Product code
- FOZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K952645 (1995). 5 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK952645 Vital Signs Saline Vascular Access Flush DeviceVital Signs, Inc. · 1995
- This deviceK982558 BD Preefile Normal Saline Flush Syringe Flush SyringeBd/Preefil · 2000
- Descendant · cites it directly · 3 of its ownK011967 BD Pre-Filled Heparin Lock Flush in 0.9% Sodium Chloride Injection…Bd · 2002
- Descendant · 2 generations on · 1 of its ownK090680 Heparin Lock Flush Solution, Usp BD Posiflush Heparin Lock Flush…Becton, Dickinson & CO · 2009
- Descendant · 3 generations on · 0 of its ownK163591 BD PosiFlush Heparin Lock Flush SyringeBecton, Dickinson and Company · 2017
- Descendant · 2 generations on · 0 of its ownK032417 Heparin Lock Flush SyringeAm2 Pat, Inc. · 2003 · Recalled
- Descendant · cites it directly · 0 of its ownK011982 0.9% Sodium Chloride Injection, Usp BD Pre-Filled Flush SyringeBd · 2001
Most influential descendants
Showing 5 of 5 · See all- K011967BD Pre-Filled Heparin Lock Flush in 0.9% Sodium Chloride Injection, Usp SyringeBd · 2002 · cites it directly3descendants
- K090680Heparin Lock Flush Solution, Usp BD Posiflush Heparin Lock Flush SyringeBecton, Dickinson & CO · 2009 · 2 generations on1descendant
- K163591BD PosiFlush Heparin Lock Flush SyringeBecton, Dickinson and Company · 2017 · 3 generations on0descendants
- K032417Heparin Lock Flush SyringeAm2 Pat, Inc. · 2003 · 2 generations on0descendants
- K0119820.9% Sodium Chloride Injection, Usp BD Pre-Filled Flush SyringeBd · 2001 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K952645 | Vital Signs Saline Vascular Access Flush Device | Vital Signs, Inc. | 1995 | — |
| 0 (this device) | 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 | — |
| +2 | K090680 | Heparin Lock Flush Solution, Usp BD Posiflush Heparin Lock Flush Syringe | Becton, Dickinson & CO | 2009 | — |
| +3 | K163591 | BD PosiFlush Heparin Lock Flush Syringe | Becton, Dickinson and Company | 2017 | — |
| +2 | K032417 | Heparin Lock Flush Syringe | Am2 Pat, Inc. | 2003 | 1 |
| +1 | K011982 | 0.9% Sodium Chloride Injection, Usp BD Pre-Filled Flush Syringe | Bd | 2001 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2009 | 1 | 0 |
| 2017 | 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 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? (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 |
|---|---|---|---|
| * | K952645 | Vital Signs Saline Vascular Access Flush DeviceSummary page 2…SIGNS PRODUCT NAME PREEFIL® SALINE VASCEZE™ HEPARIN FLUSH SYRINGE LOCK. FLUSH SOLUTION AND 0.9% SODIUM CHLORIDE, USP SOLUTION PRODUCT CODE FOZ FOZ K NUMBER NOT ASSIGNED K952645 ADDRESS MILWAUKEE, WI TOTOWA, NJ INDICATED USE MAINTENANCE OF MAINTENANCE OF PATENCY OF PATENCY OF | VASCULAR DEVICES VASCULAR DE… | 1995 |
What descends from it? (5)
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?
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?
BD Prefill Normal Saline flush syringes are intended for the maintenance of the patency of vascular access devices.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K982558 · printed Nov 5, 2026
Cite this page
510(k) Report. “K982558: BD Preefile Normal Saline Flush Syringe Flush Syringe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K982558
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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