510(k) · Cleared
Cleared0.9% Sodium Chloride Injection, USP BD PosiFlush™ SF Saline Flush Syringe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Becton, Dickinson and Company · NGT Saline, Vascular Access Flush
Cleared on Jul 21, 2023 as substantially equivalent to K153481 (Becton, Dickinson and Company, 2016) after an 88-day review. Its family tree reaches back 4 generations to 2001.
- Decided
- Jul 21, 2023
- Review
- 88 days
- Class
- Class II
- Product code
- NGT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K003553 (2001). No later device cites it as a predicate yet.
- Root · 4 generations backK003553 0.9% Sodium Chloride Injection, Usp BD Pre-Filled Flush SyringeBd Becton Dickinson Vacutainer Systems Preanalytic · 2001
- 3 generations backK042061 0.9% Sodium Chloride Injection, Usp BD Postflush SF Flush SyringeBecton Dickinson · 2004 · Recalled
- 2 generations backK121050 0.9% Sodium Chloride Injection Usp BD Posiflush Flush Syringe, SF…Becton, Dickinson & CO · 2013 · Recalled
- 1 generation backK153481 0.9% Sodium Chloride Injection, USP BD PosiFlush SF SyringeBecton, Dickinson and Company · 2016 · Recalled
- This deviceK231161 0.9% Sodium Chloride Injection, USP BD PosiFlush™ SF Saline Flush…Becton, Dickinson and Company · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K003553 | 0.9% Sodium Chloride Injection, Usp BD Pre-Filled Flush Syringe | Bd Becton Dickinson Vacutainer Systems Preanalytic | 2001 | — |
| −3 | K042061 | 0.9% Sodium Chloride Injection, Usp BD Postflush SF Flush Syringe | Becton Dickinson | 2004 | 13 |
| −2 | K121050 | 0.9% Sodium Chloride Injection Usp BD Posiflush Flush Syringe, SF Flush Syringe | Becton, Dickinson & CO | 2013 | 1 |
| −1 | K153481 | 0.9% Sodium Chloride Injection, USP BD PosiFlush SF Syringe | Becton, Dickinson and Company | 2016 | 1 |
| 0 (this device) | K231161 | 0.9% Sodium Chloride Injection, USP BD PosiFlush™ SF Saline Flush Syringe | Becton, Dickinson and Company | 2023 | — |
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 NGT? 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 NGT device
- #1 K250884 0.9 % Sodium Chloride Injection, USP, BD…score 11.6 · 5 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 |
|---|---|---|---|
| * | K153481 | 0.9% Sodium Chloride Injection, USP BD PosiFlush SF SyringeSummary page 4…0.9% Sodium Chloride Injection, USP BD PosiFlush™ SF Syringe 510(k) Number: K153481 Predicate Device Classification Name: Saline, Vascular Access Flush Regulation Number: 21 CF… | 2016 |
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 4 companies; a new generation was cleared every 7.3 years on median.
- 3 of the 4 ancestors have a recall of any class.
How does its category compare?
All NGT devicesNGT Saline, Vascular Access Flush: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · NGT
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NGT
142in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NGT
1in 2025
Class I (6 since 2007) Class II/III not classified
Adverse event reports per year · NGT
212in 2025
MAUDE reports naming product code NGT, 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 | 0 | — | 2 | 31 |
| 2008 | 1 | — | 0 | 64 |
| 2009 | 1 | — | 1 | 18 |
| 2010 | 2 | — | 7 | 23 |
| 2011 | 3 | 219 | 1 | 20 |
| 2012 | 4 | 106 | 1 | 5 |
| 2013 | 1 | — | 1 (1) | 25 |
| 2014 | 3 | 87 | 0 | 25 |
| 2015 | 1 | — | 0 | 14 |
| 2016 | 1 | — | 1 (1) | 82 |
| 2017 | 2 | — | 0 | 56 |
| 2018 | 1 | — | 0 | 270 |
| 2019 | 2 | — | 2 | 340 |
| 2020 | 2 | — | 0 | 322 |
| 2021 | 0 | — | 1 (1) | 566 |
| 2022 | 3 | 151 | 1 | 282 |
| 2023 | 6 | 142 | 3 (2) | 313 |
| 2024 | 1 | — | 0 | 332 |
| 2025 | 1 | — | 1 | 212 |
| 2026 | 0 | — | 1 (1) | — |
What is it indicated for?
The 0.9% Sodium Chloride Injection, USP, BD PosiFlush™ SF Saline Flush Syringes are intended to be used only for the flushing of indwelling vascular access devices.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231161 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231161: 0.9% Sodium Chloride Injection, USP BD PosiFlush™ SF Saline Flush Syringe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231161
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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