510(k) · Cleared
ClearedMentor Gemini Hemostatic Eraser
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mentor Ophthalmics, Inc. · HQO Unit, Cautery, Thermal, Ac-Powered
Cleared on Jul 14, 1997 after a 77-day review. The FDA summary names its predicate without a number. 3 later devices descend from it.
- Decided
- Jul 14, 1997
- Review
- 77 days
- Class
- Class II
- Product code
- HQO
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK971538 Mentor Gemini Hemostatic EraserMentor Ophthalmics, Inc. · 1997
- Descendant · cites it directly · 2 of its ownK024304 Microsurgical Bipolar HandpieceNeomedix Corp. · 2003
- Descendant · 2 generations on · 1 of its ownK040584 NMX-1000Neomedix Corp. · 2004
- Descendant · 3 generations on · 0 of its ownK220891 Kahook Dual Blade Glide (KDB Glide)New World Medical, Inc. · 2024
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K971538 | Mentor Gemini Hemostatic Eraser | Mentor Ophthalmics, Inc. | 1997 | — |
| +1 | K024304 | Microsurgical Bipolar Handpiece | Neomedix Corp. | 2003 | — |
| +2 | K040584 | NMX-1000 | Neomedix Corp. | 2004 | — |
| +3 | K220891 | Kahook Dual Blade Glide (KDB Glide) | New World Medical, Inc. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2024 | 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 HQO? 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 |
|---|---|---|---|
| * | — | Mentor® Wet-Field® Hemostatic Eraser® Bipolar Instruments Named without a submission number |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K024304 | Microsurgical Bipolar Handpiece | 2003 | 2 |
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, K024304 (Neomedix Corp., 2003) has gone furthest, with 2 descendants of its own.
How does its category compare?
All HQO devicesHQO Unit, Cautery, Thermal, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HQO
1in 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · HQO
Too few HQO 510(k)s in any year since 2007 to give a median.
Recalls per year · HQO
No recall names HQO since 2007.
Adverse event reports per year · HQO
101in 2025
MAUDE reports naming product code HQO, 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 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 13 |
| 2011 | 0 | — | 0 | 30 |
| 2012 | 0 | — | 0 | 29 |
| 2013 | 0 | — | 0 | 40 |
| 2014 | 0 | — | 0 | 55 |
| 2015 | 0 | — | 0 | 42 |
| 2016 | 0 | — | 0 | 56 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 17 |
| 2019 | 0 | — | 0 | 73 |
| 2020 | 0 | — | 0 | 44 |
| 2021 | 0 | — | 0 | 56 |
| 2022 | 0 | — | 0 | 53 |
| 2023 | 0 | — | 0 | 48 |
| 2024 | 0 | — | 0 | 66 |
| 2025 | 0 | — | 0 | 101 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Mentor® Gemini™ Hemostatic Eraser™ is used to achieve episcleral and or intraocular hemostasis utilizing diathermy.
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/K971538 · printed Nov 4, 2026
Cite this page
510(k) Report. “K971538: Mentor Gemini Hemostatic Eraser.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K971538
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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