510(k) · Cleared
Recalled · Class II · 20140.9% Sodium Chloride Injection, Usp BD Postflush SF Flush Syringe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Becton Dickinson · NGT Saline, Vascular Access Flush
Cleared on Aug 26, 2004 as substantially equivalent to K003553 (Bd Becton Dickinson Vacutainer Systems Preanalytic, 2001) after a 24-day review. Its family tree reaches back 1 generation to 2001. 7 later devices descend from it. It has been recalled 13 times.
- Decided
- Aug 26, 2004
- Review
- 24 days
- Class
- Class II
- Product code
- NGT
- Recalls
- 13
- Predicates
- 1
Its longest line of descent runs back 1 generation to K003553 (2001). 7 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK003553 0.9% Sodium Chloride Injection, Usp BD Pre-Filled Flush SyringeBd Becton Dickinson Vacutainer Systems Preanalytic · 2001
- This deviceK042061 0.9% Sodium Chloride Injection, Usp BD Postflush SF Flush SyringeBecton Dickinson · 2004
- Descendant · cites it directly · 6 of its ownK121050 0.9% Sodium Chloride Injection Usp BD Posiflush Flush Syringe, SF…Becton, Dickinson & CO · 2013 · Recalled
- Descendant · 2 generations on · 3 of its ownK141311 0.9% Sodium Chloride Injection, Usp BD Posiflush; SP Syringe, SF…Becton, Dickinson and Company · 2014
- Descendant · 3 generations on · 2 of its ownK161552 0.9% Sodium Chloride Injection, USP BD PosiFlush SP SyringeBecton, Dickinson and Company · 2017 · Recalled
- Descendant · 2 generations on · 1 of its ownK153481 0.9% Sodium Chloride Injection, USP BD PosiFlush SF SyringeBecton, Dickinson and Company · 2016 · Recalled
- Descendant · 4 generations on · 0 of its ownK250884 0.9 % Sodium Chloride Injection, USP, BD PosiFlush™ SP SyringeBecton, Dickinson and Company · 2025
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K1210500.9% Sodium Chloride Injection Usp BD Posiflush Flush Syringe, SF Flush SyringeBecton, Dickinson & CO · 2013 · cites it directly6descendants
- K1413110.9% Sodium Chloride Injection, Usp BD Posiflush; SP Syringe, SF SyringeBecton, Dickinson and Company · 2014 · 2 generations on3descendants
- K1615520.9% Sodium Chloride Injection, USP BD PosiFlush SP SyringeBecton, Dickinson and Company · 2017 · 3 generations on2descendants
- K1534810.9% Sodium Chloride Injection, USP BD PosiFlush SF SyringeBecton, Dickinson and Company · 2016 · 2 generations on1descendant
- K2508840.9 % Sodium Chloride Injection, USP, BD PosiFlush™ SP SyringeBecton, Dickinson and Company · 2025 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K003553 | 0.9% Sodium Chloride Injection, Usp BD Pre-Filled Flush Syringe | Bd Becton Dickinson Vacutainer Systems Preanalytic | 2001 | — |
| 0 (this device) | K042061 | 0.9% Sodium Chloride Injection, Usp BD Postflush SF Flush Syringe | Becton Dickinson | 2004 | — |
| +1 | K121050 | 0.9% Sodium Chloride Injection Usp BD Posiflush Flush Syringe, SF Flush Syringe | Becton, Dickinson & CO | 2013 | 1 |
| +2 | K141311 | 0.9% Sodium Chloride Injection, Usp BD Posiflush; SP Syringe, SF Syringe | Becton, Dickinson and Company | 2014 | — |
| +3 | K161552 | 0.9% Sodium Chloride Injection, USP BD PosiFlush SP Syringe | Becton, Dickinson and Company | 2017 | 3 |
| +2 | K153481 | 0.9% Sodium Chloride Injection, USP BD PosiFlush SF Syringe | Becton, Dickinson and Company | 2016 | 1 |
| +4 | K250884 | 0.9 % Sodium Chloride Injection, USP, BD PosiFlush™ SP Syringe | Becton, Dickinson and Company | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 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 |
|---|---|---|---|
| * | K003553 | 0.9% Sodium Chloride Injection, Usp BD Pre-Filled Flush SyringeSummary page 1…ckinson and Company 4. Device Description: The Predicate Device, the 0.9% Sodium Chloride Injection, USP- BD Posiflush SP Pre- Filled Flush Syringe (510(k) Number: K003553) is a single use disposable Hypodermic syringe filled with 0.9% Sodium Chloride Injection, USP and is intended for use in maintai… | 2001 |
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K121050 | 0.9% Sodium Chloride Injection Usp BD Posiflush Flush Syringe, SF Flush Syringe | 2013 | 6 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 25, 2014 | Class II | Z-0025-2015 | Nonconforming Material/Component | NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it had initiated a recall on specific lots of the syringes as some syringe unit packages exhibited open seals which may impact package integrity… |
| Aug 25, 2014 | Class II | Z-0027-2015 | Nonconforming Material/Component | NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it had initiated a recall on specific lots of the syringes as some syringe unit packages exhibited open seals which may impact package integrity… |
| Aug 25, 2014 | Class II | Z-0035-2015 | Nonconforming Material/Component | NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it had initiated a recall on specific lots of the syringes as some syringe unit packages exhibited open seals which may impact package integrity… |
| Aug 25, 2014 | Class II | Z-0026-2015 | Nonconforming Material/Component | NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it had initiated a recall on specific lots of the syringes as some syringe unit packages exhibited open seals which may impact package integrity… |
| Aug 25, 2014 | Class II | Z-0028-2015 | Nonconforming Material/Component | NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it had initiated a recall on specific lots of the syringes as some syringe unit packages exhibited open seals which may impact package integrity… |
| Aug 25, 2014 | Class II | Z-0031-2015 | Nonconforming Material/Component | NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it had initiated a recall on specific lots of the syringes as some syringe unit packages exhibited open seals which may impact package integrity… |
| Aug 25, 2014 | Class II | Z-0032-2015 | Nonconforming Material/Component | NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it had initiated a recall on specific lots of the syringes as some syringe unit packages exhibited open seals which may impact package integrity… |
| Aug 25, 2014 | Class II | Z-0033-2015 | Nonconforming Material/Component | NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it had initiated a recall on specific lots of the syringes as some syringe unit packages exhibited open seals which may impact package integrity… |
| Aug 25, 2014 | Class II | Z-0034-2015 | Nonconforming Material/Component | NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it had initiated a recall on specific lots of the syringes as some syringe unit packages exhibited open seals which may impact package integrity… |
| Aug 25, 2014 | Class II | Z-0036-2015 | Nonconforming Material/Component | NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it had initiated a recall on specific lots of the syringes as some syringe unit packages exhibited open seals which may impact package integrity… |
| Aug 25, 2014 | Class II | Z-0029-2015 | Nonconforming Material/Component | NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it had initiated a recall on specific lots of the syringes as some syringe unit packages exhibited open seals which may impact package integrity… |
| Aug 25, 2014 | Class II | Z-0030-2015 | Nonconforming Material/Component | NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it had initiated a recall on specific lots of the syringes as some syringe unit packages exhibited open seals which may impact package integrity… |
| Jul 25, 2014 | Class II | Z-2670-2014 | Packaging | Unit packages may exhibit open seals which impacts package integrity and potentially product sterility. |
The 5 latest of 13 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All NGT devicesNGT Saline, Vascular Access Flush: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Flush Syringes are intended for use in maintaining patency of vascular access devices (VAD's).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042061 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042061: 0.9% Sodium Chloride Injection, Usp BD Postflush SF 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/K042061
Report an extraction error
Are you the manufacturer?
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