510(k) · Cleared
ClearedDrainage Wick; Surgical Spears and Sponges, Corneal Light Shield, Instrument Wipe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hurricane Medical · HOZ Sponge, Ophthalmic
Cleared on May 10, 1999 after a 69-day review. The FDA summary names no predicate by number. 1 later device descends from it.
- Decided
- May 10, 1999
- Review
- 69 days
- Class
- Class II
- Product code
- HOZ
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK990671 Drainage Wick; Surgical Spears and Sponges, Corneal Light Shield…Hurricane Medical · 1999
- Descendant · cites it directly · 0 of its ownK130117 Network Eye Spears, Points, Drains, Wicks and ShieldsNetwork Medical Products, Ltd. · 2013
Most influential descendants
Showing 1 of 1 · See all- K130117Network Eye Spears, Points, Drains, Wicks and ShieldsNetwork Medical Products, Ltd. · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K990671 | Drainage Wick; Surgical Spears and Sponges, Corneal Light Shield, Instrument… | Hurricane Medical | 1999 | — |
| +1 | K130117 | Network Eye Spears, Points, Drains, Wicks and Shields | Network Medical Products, Ltd. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 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 HOZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K130117 | Network Eye Spears, Points, Drains, Wicks and Shields | 2013 | 0 |
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?
- Of its descendants, K130117 (Network Medical Products, Ltd., 2013) has gone furthest, with 0 descendants of its own.
How does its category compare?
All HOZ devicesHOZ Sponge, Ophthalmic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HOZ
2in 2013
2026 to Oct 25, outlined.
Median 510(k) review, days · HOZ
Too few HOZ 510(k)s in any year since 2007 to give a median.
Recalls per year · HOZ
3in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HOZ
3in 2025
MAUDE reports naming product code HOZ, 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 | 1 |
| 2008 | 1 | — | 0 | 2 |
| 2009 | 1 | — | 0 | 2 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 2 | — | 1 | 2 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 2 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 1 | 0 |
| 2023 | 0 | — | 0 | 6 |
| 2024 | 0 | — | 3 | 3 |
| 2025 | 0 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
These devices are used to remove excess fluid and debris from the surgical area or instrument. Also, placed on the cornea to moisten the cornea and protect the retina from the intense operating light during ophthalmic surgery.
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/K990671 · printed Nov 6, 2026
Cite this page
510(k) Report. “K990671: Drainage Wick; Surgical Spears and Sponges, Corneal Light Shield, Instrument Wipe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K990671
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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