510(k) · Cleared
ClearedFlush Syringe (Prefilled 0.9% normal saline solution)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spm Medicare Pvt., Ltd. · NGT Saline, Vascular Access Flush
Cleared on Nov 9, 2023 as substantially equivalent to K183473 (Amsino International, Inc., 2019) after a 149-day review. Its family tree reaches back 5 generations to 1999.
- Decided
- Nov 9, 2023
- Review
- 149 days
- Class
- Class II
- Product code
- NGT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K984590 (1999). No later device cites it as a predicate yet.
- Root · 5 generations backK984590 0.9% Sodium Chloride Flush SyringeBaxter Healthcare Corp · 1999 · Recalled
- 4 generations backK111034 AM Usa 0.9% Sodium Chloride Flush SyringeAm USA · 2011 · Recalled
- 3 generations backK120836 0.9% Sodium Chloride Flish SyringeAm USA · 2012 · Recalled
- 2 generations backK133685 0.9% Sodium Chloride Flush SyringeAm USA · 2014 · Recalled
- 1 generation backK183473 AMSafe (R) Pre-Filled Normal Saline Flush SyringeAmsino International, Inc. · 2019
- This deviceK231724 Flush Syringe (Prefilled 0.9% normal saline solution)Spm Medicare Pvt., Ltd. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K984590 | 0.9% Sodium Chloride Flush Syringe | Baxter Healthcare Corp | 1999 | 1 |
| −4 | K111034 | AM Usa 0.9% Sodium Chloride Flush Syringe | Am USA | 2011 | 2 |
| −3 | K120836 | 0.9% Sodium Chloride Flish Syringe | Am USA | 2012 | 2 |
| −2 | K133685 | 0.9% Sodium Chloride Flush Syringe | Am USA | 2014 | 1 |
| −1 | K183473 | AMSafe (R) Pre-Filled Normal Saline Flush Syringe | Amsino International, Inc. | 2019 | — |
| 0 (this device) | K231724 | Flush Syringe (Prefilled 0.9% normal saline solution) | Spm Medicare Pvt., Ltd. | 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 |
|---|---|---|---|
| * | K183473 | AMSafe (R) Pre-Filled Normal Saline Flush SyringeSummary page 6…Page 1 of 6 c) Identification of Legally Marketed Device(s): Flush Syringe, 510K number K183473. d) Device Description: Flush Syringe (Prefilled 0.9% normal saline solution) is a polypropylene plastic syringe filled w… | 2019 |
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 24 years and passes through 4 companies; a new generation was cleared every 4.3 years on median.
- 4 of the 5 ancestors have a recall of any class.
- 1 other device also cites its predicate K183473.
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?
Flush Syringe (Prefilled 0.9% normal saline solution) is intended for use in flushing compatible intravenous administration sets and indwelling intravenous access devices.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231724 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231724: Flush Syringe (Prefilled 0.9% normal saline solution).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231724
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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