510(k) · Cleared
Recalled · 20020.9% Sodium Chloride Flush Syringe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Baxter Healthcare Corp · FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Cleared on Oct 7, 1999 after a 283-day review. The FDA summary names its predicate without a number. 1 of the 11 devices in its family, counting itself, has a Class I recall. 10 later devices descend from it. It has been recalled once.
- Decided
- Oct 7, 1999
- Review
- 283 days
- Class
- Class II
- Product code
- FOZ
- Recalls
- 1
- Predicates
- 0
10 later devices descend from it, 1 citing it directly. 1 of the 11 devices in this family, counting this one, has a Class I recall.
- This deviceK984590 0.9% Sodium Chloride Flush SyringeBaxter Healthcare Corp · 1999
- Descendant · cites it directly · 9 of its ownK111034 AM Usa 0.9% Sodium Chloride Flush SyringeAm USA · 2011 · Recalled
- Descendant · 2 generations on · 6 of its ownK120836 0.9% Sodium Chloride Flish SyringeAm USA · 2012 · Recalled
- Descendant · 3 generations on · 5 of its ownK133685 0.9% Sodium Chloride Flush SyringeAm USA · 2014 · Recalled
- Descendant · 4 generations on · 4 of its ownK183473 AMSafe (R) Pre-Filled Normal Saline Flush SyringeAmsino International, Inc. · 2019
- Descendant · 5 generations on · 2 of its ownK213522 AMSafe Pre-Filled Normal Saline Flush SyringeAmsino International, Inc. · 2022
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K150143 Normal Saline Flush2 generations on · 2015
Most influential descendants
Showing 5 of 10 · See all- K111034AM Usa 0.9% Sodium Chloride Flush SyringeAm USA · 2011 · cites it directly9descendants
- K1208360.9% Sodium Chloride Flish SyringeAm USA · 2012 · 2 generations on6descendants
- K1336850.9% Sodium Chloride Flush SyringeAm USA · 2014 · 3 generations on5descendants
- K183473AMSafe (R) Pre-Filled Normal Saline Flush SyringeAmsino International, Inc. · 2019 · 4 generations on4descendants
- K213522AMSafe Pre-Filled Normal Saline Flush SyringeAmsino International, Inc. · 2022 · 5 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K984590 | 0.9% Sodium Chloride Flush Syringe | Baxter Healthcare Corp | 1999 | — |
| +1 | K111034 | AM Usa 0.9% Sodium Chloride Flush Syringe | Am USA | 2011 | 2 |
| +2 | K120836 | 0.9% Sodium Chloride Flish Syringe | Am USA | 2012 | 2 |
| +3 | K133685 | 0.9% Sodium Chloride Flush Syringe | Am USA | 2014 | 1 |
| +4 | K183473 | AMSafe (R) Pre-Filled Normal Saline Flush Syringe | Amsino International, Inc. | 2019 | — |
| +5 | K213522 | AMSafe Pre-Filled Normal Saline Flush Syringe | Amsino International, Inc. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 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 FOZ device
- #1 K243403 BD Nexiva™ Closed IV Catheter Systemscore 14.8 · 8 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 |
|---|---|---|---|
| * | — | Abbott prefilled syringe with 0.9% sodium chloride solution Named without a submission number |
What descends from it? (10)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K111034 | AM Usa 0.9% Sodium Chloride Flush Syringe | 2011 | 9 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 12, 2002 | Not classified | Z-0456-03 | Other | Sterility questioned |
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 · 2 generations on · ◆ in the 2015 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K111034 (Am USA, 2011) has gone furthest, with 9 descendants of its own.
How does its category compare?
All FOZ devicesFOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FOZ
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FOZ
91in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FOZ
4in 2023
Class I (5 since 2007) Class II/III not classified
Adverse event reports per year · FOZ
5,110in 2025
MAUDE reports naming product code FOZ, 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 | 6 | 159 | 16 | 374 |
| 2008 | 9 | 103 | 0 | 422 |
| 2009 | 9 | 30 | 23 | 508 |
| 2010 | 3 | 28 | 115 | 370 |
| 2011 | 6 | 132 | 0 | 786 |
| 2012 | 13 | 122 | 0 | 560 |
| 2013 | 4 | 104 | 2 | 640 |
| 2014 | 9 | 99 | 4 | 815 |
| 2015 | 10 | 107 | 0 | 729 |
| 2016 | 9 | 63 | 3 (1) | 925 |
| 2017 | 9 | 51 | 22 | 1,966 |
| 2018 | 1 | — | 4 | 3,305 |
| 2019 | 8 | 140 | 3 | 4,365 |
| 2020 | 10 | 191 | 3 | 3,797 |
| 2021 | 4 | 242 | 1 | 4,674 |
| 2022 | 8 | 183 | 4 (2) | 4,133 |
| 2023 | 9 | 129 | 4 (2) | 4,430 |
| 2024 | 6 | 190 | 0 | 4,772 |
| 2025 | 11 | 91 | 0 | 5,110 |
| 2026 | 7 | 203 | 2 | — |
What is it indicated for?
The 0.9% Sodium Chloride Flush Syringe is indicated for use in flushing compatible intravenous tubing systems and indwelling intravascular access devices.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K984590 · printed Nov 4, 2026
Cite this page
510(k) Report. “K984590: 0.9% Sodium Chloride Flush Syringe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K984590
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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