510(k) · Cleared
ClearedSterile Saline Solution 0.9%- Catalog NO, 10290, Sterile Water- Catalog NO. 10291
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Acu-Pak · FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Cleared on Aug 18, 1998 as substantially equivalent to K922033 (Trinity Laboratories, Inc., 1992) and 1 other predicate after a 78-day review. Its family tree reaches back 1 generation to 1992.
- Decided
- Aug 18, 1998
- Review
- 78 days
- Class
- Class II
- Product code
- FOZ
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 1 generation to K922033 (1992). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK922033 Saline Solution- SterileTrinity Laboratories, Inc. · 1992
- This deviceK981905 Sterile Saline Solution 0.9%- Catalog NO, 10290, Sterile Water-…Acu-Pak · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K922033 | Saline Solution- Sterile | Trinity Laboratories, Inc. | 1992 | — |
| 0 (this device) | K981905 | Sterile Saline Solution 0.9%- Catalog NO, 10290, Sterile Water- Catalog NO.… | Acu-Pak | 1998 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 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.
Planning a device in FOZ? 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? (5)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K922033 | Saline Solution- SterileSummary page 1…Fax (603) 668-1102 Carol Thompson Regulatory Manager 05/29/98 Sterile Saline Solution 0.9% and Sterile Water Sterile Saline, Sterile Water Catheter and Tip, Suction K922033 - Saline Solution 0.9% K933526 - Sterile Water Trinity Laboratories Salisbury, MD 21801 KA05950 - Sterile Saline Solution KF11… | 1992 |
| * | K933526 | Sterile WaterSummary page 1…pson Regulatory Manager 05/29/98 Sterile Saline Solution 0.9% and Sterile Water Sterile Saline, Sterile Water Catheter and Tip, Suction K922033 - Saline Solution 0.9% K933526 - Sterile Water Trinity Laboratories Salisbury, MD 21801 KA05950 - Sterile Saline Solution KF11560 - Sterile Water Superior P… | 1994 |
| Kept off the family tree | K405950 | Sterile Saline Solution Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | |
| Kept off the family tree | K111560 | FDA’s K111560 is Wondfo Amphetamine Urine Test, Wondfo Barbiturates Urine Test, Wondfo… Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2011 |
| * | — | 0.9% Isotonic Saline, Sterile; Sterile Water Named without a submission number |
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?
- None of the 2 ancestors has a recall.
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?
ACU-PAX Sterile Saline Solution 0.9% / Sterile Water are used in health care facilities for the irrigation of general medical devices. It is used as a lubricant for suction catheters.
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/K981905 · printed Nov 4, 2026
Cite this page
510(k) Report. “K981905: Sterile Saline Solution 0.9%- Catalog NO, 10290, Sterile Water- Catalog NO. 10291.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K981905
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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