510(k) · Cleared
Recalled · Class I · 2016Normal Saline Flush
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nurse Assist, Inc. · NGT Saline, Vascular Access Flush
Cleared on Aug 31, 2015 as substantially equivalent to K111034 (Am USA, 2011) after a 221-day review. Its family tree reaches back 2 generations to 1999. 1 of the 3 devices in its family, counting itself, has a Class I recall. It has been recalled once, including a Class I recall.
- Decided
- Aug 31, 2015
- Review
- 221 days
- Class
- Class II
- Product code
- NGT
- Recalls
- 1 (1 Class I)
- Predicates
- 1
Its longest line of descent runs back 2 generations to K984590 (1999). No later device cites it as a predicate yet. 1 of the 3 devices in this family, counting this one, has a Class I recall.
View FIG. 1 as a table
Line of descent and top descendants
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.
1 device in this family has 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? (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 |
|---|---|---|---|
| * | K111034 | AM Usa 0.9% Sodium Chloride Flush SyringeSummary page 4…oduct Code: NGT 6. Legally marketed device to which substantial equivalence is claimed: Primary predicate – AMUSA 0.9% Sodium Chloride Flush Syringe, K111034 Reference device – Kendall Monoject Prefill Flush Syringe, K032438 7. Description of the device: The subject device… | 2011 |
| † | K032438 | Modification to: Monojet Prefill 0.9% Sodium Chloride Flush Syringe, Monojet Prefill… | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 4, 2016 | Class I | Z-0926-2017 | Unknown/Undetermined by firm | Potential contamination with B. cepacia. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 3 companies; a new generation was cleared every 11.8 years on median.
- 2 of the 2 ancestors have a recall of any class.
- 2 other devices also cite its predicate K111034.
How does its category compare?
All NGT devicesNGT Saline, Vascular Access Flush: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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?
This device 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/K150143 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150143: Normal Saline Flush.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150143
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