510(k) · Cleared
Recalled · Class I · 2026Sodium Chloride Injection, 0.9%, Usp 5 ML, 10 ML Ampule
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spectra Medical Devices, Inc. · NGT Saline, Vascular Access Flush
Cleared on Jul 29, 2011 as substantially equivalent to K082689 (Spectra Medical Devices, Inc., 2009) and 1 other predicate after a 219-day review. Its family tree reaches back 2 generations to 2003. 2 of the 3 devices in its family, counting itself, have a Class I recall. It has been recalled once, including a Class I recall.
- Decided
- Jul 29, 2011
- Review
- 219 days
- Class
- Class II
- Product code
- NGT
- Recalls
- 1 (1 Class I)
- Predicates
- 2
Its longest line of descent runs back 2 generations to K023740 (2003). No later device cites it as a predicate yet. 2 of the 3 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backK023740 Syrex Pre-Filled SyringeExcelsior Medical Corp. · 2003 · Recalled
- 1 generation backK082689 Sterile Sodium Chloride 0.9% Flush, 5ML, 10ML, AmpuleSpectra Medical Devices, Inc. · 2009 · Recalled (Class I)
- This deviceK103740 Sodium Chloride Injection, 0.9%, Usp 5 ML, 10 ML AmpuleSpectra Medical Devices, Inc. · 2011
Class I recalls in this family
- K082689 Sterile Sodium Chloride 0.9% Flush, 5ML, 10ML…direct predicate · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K023740 | Syrex Pre-Filled Syringe | Excelsior Medical Corp. | 2003 | 1 |
| −1 | K082689 | Sterile Sodium Chloride 0.9% Flush, 5ML, 10ML, Ampule | Spectra Medical Devices, Inc. | 2009 | Class I |
| 0 (this device) | K103740 | Sodium Chloride Injection, 0.9%, Usp 5 ML, 10 ML Ampule | Spectra Medical Devices, Inc. | 2011 | — |
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.
2 devices in this family have a Class I recall. 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? (2)
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 |
|---|---|---|---|
| * | K082689 | Sterile Sodium Chloride 0.9% Flush, 5ML, 10ML, AmpuleSummary page 2…systems and in dwelling intravascular access devices. Not to be used for any other purposes. 5. PREDICATE DEVICE a. K082689 - Sodium Chloride Injection, 0.9%, USP 10 Ml Ampule K023740 - Syrex Pre-filled Syringe with 0.9% Sodium Chl… | 2009 |
| * | K023740 | Syrex Pre-Filled SyringeSummary page 2…other purposes. 5. PREDICATE DEVICE a. K082689 - Sodium Chloride Injection, 0.9%, USP 10 Ml Ampule K023740 - Syrex Pre-filled Syringe with 0.9% Sodium Chloride b. Substantial Eqiuivalence Comparison… | 2003 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 6, 2026 | Class I | Z-2873-2026 | Nonconforming Material/Component | Manufacturing firm, Huons, was cited for issues regarding product quality and sterility assurance. If the product sterility is compromised, patients may be exposed to microorganisms, endotoxins, or foreign matter. This may trigger… |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K082689Sterile Sodium Chloride 0.9% Flush, 5ML, 10ML, AmpuleSpectra Medical Devices, Inc. · 2009 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 8 years and passes through 2 companies; a new generation was cleared every 5.9 years on median.
- 2 of the 2 ancestors have a recall of any class; 1 has a Class I recall.
How does its category compare?
All NGT devicesNGT Saline, Vascular Access Flush: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 device is indicated only for use in flushing compatible intravenous tubing systems and in dwelling intravascular access devices. Not to be used for any other purposes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103740 · printed Nov 5, 2026
Cite this page
510(k) Report. “K103740: Sodium Chloride Injection, 0.9%, Usp 5 ML, 10 ML Ampule.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K103740
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