510(k) · Cleared
ClearedStorz Ophthalmic Bipolar Cautery Instruments (D8200, D8201, D8203) and Bipolar Cords (D8202, D8204)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Storz · HQR Apparatus, Cautery, Radiofrequency, Ac-Powered
Cleared on Mar 4, 1996 after a 301-day review. The FDA summary names its predicate without a number. 3 later devices descend from it.
- Decided
- Mar 4, 1996
- Review
- 301 days
- Class
- Class II
- Product code
- HQR
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK952151 Storz Ophthalmic Bipolar Cautery Instruments (D8200, D8201, D8203)…Storz · 1996
- 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) | K952151 | Storz Ophthalmic Bipolar Cautery Instruments (D8200, D8201, D8203) and Bipolar… | Storz | 1996 | — |
| +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 HQR? 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? (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 |
|---|---|---|---|
| * | — | Kirwan Ophthalmic Bipolar Forceps, Bipolar Pencils, and Bipolar Cord Named without a submission number | |
| * | — | Mentor WET-FIELD Bipolar Forceps and Bipolar Hemostatic Erasers 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 HQR devicesHQR Apparatus, Cautery, Radiofrequency, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HQR
FDA has decided no HQR device since 2007.
Median 510(k) review, days · HQR
Too few HQR 510(k)s in any year since 2007 to give a median.
Recalls per year · HQR
No recall names HQR since 2007.
Adverse event reports per year · HQR
3in 2024
MAUDE reports naming product code HQR, 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 | 0 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 5 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 4 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 3 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 3 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Storz Ophthalmic Bipolar Cautery devices are used to control bleeding during ophthalmic surgical procedures using radiofrequency electric current. The D8200 Bipolar Forceps are used during ophthalmic procedures, coagulating extraocular tissue by pinching it between the forcep tips. The D8201 Bipolar Eraser is also used during surgery for cauterization of extraocular vessels, while the D8203 Bipolar Intraocular Eraser is used in posterior ophthalmic surgical procedures to cauterize vessels internal to the eye.
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/K952151 · printed Nov 6, 2026
Cite this page
510(k) Report. “K952151: Storz Ophthalmic Bipolar Cautery Instruments (D8200, D8201, D8203) and Bipolar Cords (D8202, D8204).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K952151
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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