510(k) · Cleared
ClearedPre-Filled Catheter Inflation Syringe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Avail Medical Products, Inc. · KNY Accessories, Catheter, G-U
Cleared on Apr 15, 2009 as substantially equivalent to K952414 (Acacia Laboratories, Inc., 1995) after an 84-day review. Its family tree reaches back 1 generation to 1995.
- Decided
- Apr 15, 2009
- Review
- 84 days
- Class
- Class II
- Product code
- KNY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K952414 (1995). No later device cites it as a predicate yet.
- Root · 1 generation backK952414 Prefilled Syringe for Inflation of Foley CatheterAcacia Laboratories, Inc. · 1995
- This deviceK090121 Pre-Filled Catheter Inflation SyringeAvail Medical Products, Inc. · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K952414 | Prefilled Syringe for Inflation of Foley Catheter | Acacia Laboratories, Inc. | 1995 | — |
| 0 (this device) | K090121 | Pre-Filled Catheter Inflation Syringe | Avail Medical Products, Inc. | 2009 | — |
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 KNY? 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 KNY device
- #1 K260919 Transurethral Catheter Safety Valve (TUCSV)…score 11.8 · 1 generation · no Class I recall
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 |
|---|---|---|---|
| * | K952414 | Prefilled Syringe for Inflation of Foley CatheterSummary page 1…214-580-7039 Name of Device: Avail Sterile, Latex Free, Water Filled Syringe Predicate Device: Horizon Prefilled Syringe For Inflation Of Foley Catheter, K95241 4 Description of the New Device: The Avail Stenle. Latex Free, Water Filled Syringe is a sterile, single patient use, disposable de… | 1995 |
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?
- Its one ancestor has no recall.
How does its category compare?
All KNY devicesKNY Accessories, Catheter, G-U: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · KNY
1in 2018
2026 to Oct 25, outlined.
Median 510(k) review, days · KNY
103in 2014
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KNY
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KNY
3in 2025
MAUDE reports naming product code KNY, 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 | — | 0 | 15 |
| 2008 | 0 | — | 0 | 19 |
| 2009 | 1 | — | 0 | 10 |
| 2010 | 0 | — | 0 | 12 |
| 2011 | 1 | — | 1 | 6 |
| 2012 | 1 | — | 0 | 5 |
| 2013 | 2 | — | 0 | 8 |
| 2014 | 3 | 103 | 0 | 7 |
| 2015 | 0 | — | 0 | 13 |
| 2016 | 0 | — | 0 | 19 |
| 2017 | 1 | — | 0 | 21 |
| 2018 | 1 | — | 0 | 17 |
| 2019 | 0 | — | 0 | 19 |
| 2020 | 0 | — | 0 | 36 |
| 2021 | 0 | — | 0 | 17 |
| 2022 | 0 | — | 0 | 19 |
| 2023 | 0 | — | 0 | 13 |
| 2024 | 0 | — | 1 | 5 |
| 2025 | 0 | — | 0 | 3 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Avail Sterile, Latex Free, Water Filled Syringe is intended to be used to provide
sterile water for catheter inflation after insertion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090121 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090121: Pre-Filled Catheter Inflation Syringe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090121
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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