510(k) · Cleared
ClearedSuntouch Eye Spear
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Huizhou Foryou Medical Devices Co., Ltd. · HOZ Sponge, Ophthalmic
Cleared on Oct 30, 2013 as substantially equivalent to K002279 (Med-Logics, Inc., 2000) after a 54-day review. Its family tree reaches back 1 generation to 2000.
- Decided
- Oct 30, 2013
- Review
- 54 days
- Class
- Class II
- Product code
- HOZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K002279 (2000). No later device cites it as a predicate yet.
- Root · 1 generation backK002279 ML Eye Spear, Model ML 27 ESMed-Logics, Inc. · 2000
- This deviceK132796 Suntouch Eye SpearHuizhou Foryou Medical Devices Co., Ltd. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K002279 | ML Eye Spear, Model ML 27 ES | Med-Logics, Inc. | 2000 | — |
| 0 (this device) | K132796 | Suntouch Eye Spear | Huizhou Foryou Medical Devices Co., Ltd. | 2013 | — |
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? (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 |
|---|---|---|---|
| * | K002279 | ML Eye Spear, Model ML 27 ESSummary page 2…d to absorb fluids and remove debris from the operative field or instruments during ophthalmic surgery. 5. Predicate Device Identification 510(k) Number: K002279 Product Name: ML Eye Spear Manufacturer: Med-Logics, Inc 6. Device Description SUNTOUCHO Eye Spears are ster… | 2000 |
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 HOZ devicesHOZ Sponge, Ophthalmic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
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?
The Eye Spears are designed to absorb fluids and remove debris from the operative field or instruments during ophthalmic surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132796 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132796: Suntouch Eye Spear.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132796
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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