510(k) · Cleared
ClearedExpandacell Eye Spear, Eye Wick, Wick Drain and Corneal Shield
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shippert Medical Technologies Corp. · HOZ Sponge, Ophthalmic
Cleared on Mar 4, 1997 after a 90-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
- Decided
- Mar 4, 1997
- Review
- 90 days
- Class
- Class II
- Product code
- HOZ
- Recalls
- None
- Predicates
- 0
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
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.
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 | — |
https://510kreport.com/device/K964855 · printed Nov 4, 2026
Cite this page
510(k) Report. “K964855: Expandacell Eye Spear, Eye Wick, Wick Drain and Corneal Shield.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K964855
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026