510(k) · Cleared
ClearedHydraclear Pump Console, Hydraclear Power Supplly, Hydraclear Footswitch, Hydraclear Sheaths, Hydraclear Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gyrus Ent LLC · EOB Nasopharyngoscope (Flexible Or Rigid)
Cleared on Feb 2, 1999 as substantially equivalent to K973286 (Gyrus Ent LLC, 1997) and 1 other predicate after an 11-day review. Its family tree reaches back 1 generation to 1993.
- Decided
- Feb 2, 1999
- Review
- 11 days
- Class
- Class II
- Product code
- EOB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K932988 (1993). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK932988 Accessories for Endoscopes for Sinus SurgerySmith & Nephew Richards, Inc. · 1993
- This deviceK990213 Hydraclear Pump Console, Hydraclear Power Supplly, Hydraclear…Gyrus Ent LLC · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K932988 | Accessories for Endoscopes for Sinus Surgery | Smith & Nephew Richards, Inc. | 1993 | — |
| 0 (this device) | K990213 | Hydraclear Pump Console, Hydraclear Power Supplly, Hydraclear Footswitch… | Gyrus Ent LLC | 1999 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 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 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? (2)
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 |
|---|---|---|---|
| * | K973286 | Ent Irrigating Pump (70327700)Summary page 1…iries: 1-800-238-7538 Smith=rNephew | Exhibit H 510(k) Summary of Safcty and Effcctivencss HydraClear™ Irrigating System Modification to the ENTire™ Irrigating Pump (K973286) and Accessories to Endoscope (K932988) Electrical Irrigating Pump and Accessories to Endoscopes Nasopharyngoscope (flexible or… | 1997 |
| * | K932988 | Accessories for Endoscopes for Sinus SurgerySummary page 1…Exhibit H 510(k) Summary of Safcty and Effcctivencss HydraClear™ Irrigating System Modification to the ENTire™ Irrigating Pump (K973286) and Accessories to Endoscope (K932988) Electrical Irrigating Pump and Accessories to Endoscopes Nasopharyngoscope (flexible or rigid) and Accessories (21 CFR 874.476… | 1993 |
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 EOB devicesEOB Nasopharyngoscope (Flexible Or Rigid): FDA decisions, review times, recalls and adverse event reports over 20 years.
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 HydraClear System is intended for endoscopic sinus surgery, to irrigate the surgical site, and for the removal of blood and tissue deposits from the surface of the sinusope lens.
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/K990213 · printed Nov 5, 2026
Cite this page
510(k) Report. “K990213: Hydraclear Pump Console, Hydraclear Power Supplly, Hydraclear Footswitch, Hydraclear Sheaths, Hydraclear Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K990213
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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