510(k) · Cleared
Recalled · Class III · 2012AM Usa 0.9% Sodium Chloride Flush Syringe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Am USA · NGT Saline, Vascular Access Flush
Cleared on Jul 14, 2011 as substantially equivalent to K984590 (Baxter Healthcare Corp, 1999) after a 92-day review. Its family tree reaches back 1 generation to 1999. 1 of the 11 devices in its family, counting itself, has a Class I recall. 9 later devices descend from it. It has been recalled 2 times.
- Decided
- Jul 14, 2011
- Review
- 92 days
- Class
- Class II
- Product code
- NGT
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 1 generation to K984590 (1999). 9 later devices descend from it, 3 citing it directly. 1 of the 11 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK984590 0.9% Sodium Chloride Flush SyringeBaxter Healthcare Corp · 1999 · Recalled
- This deviceK111034 AM Usa 0.9% Sodium Chloride Flush SyringeAm USA · 2011
- Descendant · cites it directly · 6 of its ownK120836 0.9% Sodium Chloride Flish SyringeAm USA · 2012 · Recalled
- Descendant · 2 generations on · 5 of its ownK133685 0.9% Sodium Chloride Flush SyringeAm USA · 2014 · Recalled
- Descendant · 3 generations on · 4 of its ownK183473 AMSafe (R) Pre-Filled Normal Saline Flush SyringeAmsino International, Inc. · 2019
- Descendant · 4 generations on · 2 of its ownK213522 AMSafe Pre-Filled Normal Saline Flush SyringeAmsino International, Inc. · 2022
- Descendant · 4 generations on · 0 of its ownK231724 Flush Syringe (Prefilled 0.9% normal saline solution)Spm Medicare Pvt., Ltd. · 2023
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K150143 Normal Saline Flushcites it directly · 2015
Most influential descendants
Showing 5 of 9 · See all- K1208360.9% Sodium Chloride Flish SyringeAm USA · 2012 · cites it directly6descendants
- K1336850.9% Sodium Chloride Flush SyringeAm USA · 2014 · 2 generations on5descendants
- K183473AMSafe (R) Pre-Filled Normal Saline Flush SyringeAmsino International, Inc. · 2019 · 3 generations on4descendants
- K213522AMSafe Pre-Filled Normal Saline Flush SyringeAmsino International, Inc. · 2022 · 4 generations on2descendants
- K231724Flush Syringe (Prefilled 0.9% normal saline solution)Spm Medicare Pvt., Ltd. · 2023 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K984590 | 0.9% Sodium Chloride Flush Syringe | Baxter Healthcare Corp | 1999 | 1 |
| 0 (this device) | K111034 | AM Usa 0.9% Sodium Chloride Flush Syringe | Am USA | 2011 | — |
| +1 | K120836 | 0.9% Sodium Chloride Flish Syringe | Am USA | 2012 | 2 |
| +2 | K133685 | 0.9% Sodium Chloride Flush Syringe | Am USA | 2014 | 1 |
| +3 | K183473 | AMSafe (R) Pre-Filled Normal Saline Flush Syringe | Amsino International, Inc. | 2019 | — |
| +4 | K213522 | AMSafe Pre-Filled Normal Saline Flush Syringe | Amsino International, Inc. | 2022 | — |
| +4 | K231724 | Flush Syringe (Prefilled 0.9% normal saline solution) | Spm Medicare Pvt., Ltd. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 1 |
| 2019 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 3 | 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.
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 |
|---|---|---|---|
| * | K984590 | 0.9% Sodium Chloride Flush SyringeSummary page 2…venous access devices. Use according to the recommendations of the manufacture for the appropriate device. DEVICE DESCRIPTION- The Predicate Device, 510(k) Number: K984590 (Baxter Healthcare), consists of a sterile plastic syringe aseptically filled with 0.9% Sodium Chloride Flush Solution. The pre… | 1999 |
What descends from it? (9)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 15, 2012 | Class III | Z-2394-2012 | Employee error | One lot of 0.9% Sodium Chloride Flush syringe, 3 mL in 12 mL may be mislabeled as 0.9% Sodium Chloride Flush syringe, 10 mL in 12 mL. |
| Aug 15, 2012 | Class III | Z-2393-2012 | Employee error | One lot of 0.9% Sodium Chloride Flush syringe, 3 mL in 12 mL may be mislabeled as 0.9% Sodium Chloride Flush syringe, 10 mL in 12 mL. |
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.
- K150143Normal Saline FlushNurse Assist, Inc. · 2015 · Cites it directly · ◆ in the 2015 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Its one ancestor has a recall.
- Of its descendants, K120836 (Am USA, 2012) has gone furthest, with 6 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. 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?
0.9% Sodium Chloride Flush Syringes are intended for use in flushing compatible intravenous administration sets and indwelling intravenous access devices. Use according to the recommendations of the manufacture for the appropriate device.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111034 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111034: AM Usa 0.9% Sodium Chloride 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/K111034
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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