510(k) · Cleared
Recalled · Class II · 20230.9% Sodium Chloride Injection, USP BD PosiFlush SP 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 Feb 2, 2017 as substantially equivalent to K141311 (Becton, Dickinson and Company, 2014) after a 241-day review. Its family tree reaches back 4 generations to 2001. 2 later devices descend from it. It has been recalled 3 times.
- Decided
- Feb 2, 2017
- Review
- 241 days
- Class
- Class II
- Product code
- NGT
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 4 generations to K003553 (2001). 2 later devices descend from it, 2 citing it directly.
- 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 backK141311 0.9% Sodium Chloride Injection, Usp BD Posiflush; SP Syringe, SF…Becton, Dickinson and Company · 2014
- This deviceK161552 0.9% Sodium Chloride Injection, USP BD PosiFlush SP SyringeBecton, Dickinson and Company · 2017
- Descendant · cites it directly · 0 of its ownK250884 0.9 % Sodium Chloride Injection, USP, BD PosiFlush™ SP SyringeBecton, Dickinson and Company · 2025
- Descendant · cites it directly · 0 of its ownK213955 0.9% Sodium Chloride Injection, USP, BD PosiFlush SafeScrubBecton, Dickinson and Company · 2022
Most influential descendants
Showing 2 of 2 · See allView 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 | K141311 | 0.9% Sodium Chloride Injection, Usp BD Posiflush; SP Syringe, SF Syringe | Becton, Dickinson and Company | 2014 | — |
| 0 (this device) | K161552 | 0.9% Sodium Chloride Injection, USP BD PosiFlush SP Syringe | Becton, Dickinson and Company | 2017 | — |
| +1 | K250884 | 0.9 % Sodium Chloride Injection, USP, BD PosiFlush™ SP Syringe | Becton, Dickinson and Company | 2025 | — |
| +1 | K213955 | 0.9% Sodium Chloride Injection, USP, BD PosiFlush SafeScrub | Becton, Dickinson and Company | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2025 | 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 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 |
|---|---|---|---|
| * | K141311 | 0.9% Sodium Chloride Injection, Usp BD Posiflush; SP Syringe, SF SyringeSummary page 4…Chloride Injection, USP, BD PosiFlush™ SP Syringe 510(k) Reference: K141311 Common Name: 0.9% Sodium Chloride Injection Flush Syringe… | 2014 |
What descends from it? (2)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 16, 2023 | Class II | Z-0736-2024 | Under Investigation by firm | An incorrect stopper was used in nine lots of 10mL BD PosiFlush Normal Saline Flush Syringes with General Pump Compatibility. The use of BD PosiFlush Prefilled Flush Syringes with this stopper causes an increase in injection force, which… |
| Oct 14, 2019 | Class II | Z-0499-2020 | Packaging process control | Limited number of syringes labeled Posiflush Experimental Product and Not for Human Use being mixed with standard BD Posiflush Pre-Filled Normal Saline Syringes. |
| Oct 14, 2019 | Class II | Z-0500-2020 | Packaging process control | Limited number of syringes labeled Posiflush Experimental Product and Not for Human Use being mixed with standard BD Posiflush Pre-Filled Normal Saline Syringes. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 4 companies; a new generation was cleared every 3.4 years on median.
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K250884 (Becton, Dickinson and Company, 2025) has gone furthest, with 0 descendants of its own.
How does its category compare?
All NGT devicesNGT Saline, 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 · 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™ SP Syringe is intended to be used only for the flushing of indwelling vascular access devices. Catalog Number 306547 10 mL BD PosiFlush™ SP Syringes are generally compatible for use with syringe pumps.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161552 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161552: 0.9% Sodium Chloride Injection, USP BD PosiFlush SP Syringe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161552
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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