510(k) · Cleared
ClearedHydro Irrigation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Instruments · EOB Nasopharyngoscope (Flexible Or Rigid)
Cleared on Jun 17, 2026 as substantially equivalent to K013838 (KARL STORZ Endoscopy-America, Inc., 2002) after a 40-day review. Its family tree reaches back 1 generation to 2002.
- Decided
- Jun 17, 2026
- Review
- 40 days
- Class
- Class II
- Product code
- EOB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K013838 (2002). No later device cites it as a predicate yet.
- Root · 1 generation backK013838 Ksea Clearvision Lens Irrigation SystemKARL STORZ Endoscopy-America, Inc. · 2002
- This deviceK261544 Hydro Irrigation SystemStryker Instruments · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K013838 | Ksea Clearvision Lens Irrigation System | KARL STORZ Endoscopy-America, Inc. | 2002 | — |
| 0 (this device) | K261544 | Hydro Irrigation System | Stryker Instruments | 2026 | — |
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 EOB? 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 EOB device
- #1 K253184 Video Rhinolaryngoscope System (Disposable…score 14.4 · 12 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 |
|---|---|---|---|
| * | K013838 | Ksea Clearvision Lens Irrigation SystemSummary page 5…oduct Code: EOB 510(k) Review Panel: Ear, Nose, & Throat Predicate Device(s): Karl Storz Clearvision Len Irrigation System K013838 (predicate) Hydro Irrigation System K253679 (reference) Smith & Nephew ENTire Irrigation P… | 2002 |
| † | K253679 | Hydro Irrigation System | 2026 |
| † | K973286 | Ent Irrigating Pump (70327700) | 1997 |
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.
- 2 other devices also cite its predicate K013838.
How does its category compare?
All EOB devicesEOB Nasopharyngoscope (Flexible Or Rigid): FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · EOB
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EOB
192in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EOB
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EOB
1,338in 2025
MAUDE reports naming product code EOB, 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 | 4 | 37 | 0 | 1 |
| 2008 | 4 | 38 | 0 | 1 |
| 2009 | 1 | — | 0 | 3 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 4 | 209 | 2 | 3 |
| 2012 | 1 | — | 0 | 4 |
| 2013 | 0 | — | 0 | 5 |
| 2014 | 3 | 282 | 0 | 5 |
| 2015 | 3 | 115 | 0 | 13 |
| 2016 | 3 | 174 | 0 | 16 |
| 2017 | 6 | 216 | 0 | 18 |
| 2018 | 6 | 230 | 0 | 23 |
| 2019 | 8 | 149 | 0 | 51 |
| 2020 | 3 | 175 | 0 | 47 |
| 2021 | 2 | — | 0 | 345 |
| 2022 | 6 | 178 | 1 | 1,158 |
| 2023 | 3 | 107 | 1 | 1,352 |
| 2024 | 2 | — | 0 | 1,498 |
| 2025 | 3 | 192 | 0 | 1,338 |
| 2026 | 5 | 180 | 1 | — |
What is it indicated for?
The Hydro Irrigation Console (console) and its accessories (also referred to as the Hydro Irrigation System) are intended for cleaning the distal lens of rigid endoscopes and maintaining clear visualization without removing the scope from the surgical site during otolaryngology procedures.
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/K261544 · printed Nov 6, 2026
Cite this page
510(k) Report. “K261544: Hydro Irrigation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K261544
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026