510(k) · Cleared
ClearedDI-Rhex Ophthalmic Diathermy System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ophthalmic Technologies, Inc. · HQR Apparatus, Cautery, Radiofrequency, Ac-Powered
Cleared on Apr 4, 1999 as substantially equivalent to K962135 (Dutch Ophthalmic USA, Inc., 1996) and 1 other predicate after an 86-day review. Its family tree reaches back 1 generation to 1996.
- Decided
- Apr 4, 1999
- Review
- 86 days
- Class
- Class II
- Product code
- HQR
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K962135 (1996). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK962135 D.O.R.C. Microdiathermy SystemDutch Ophthalmic USA, Inc. · 1996
- This deviceK990064 DI-Rhex Ophthalmic Diathermy SystemOphthalmic Technologies, Inc. · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K962135 | D.O.R.C. Microdiathermy System | Dutch Ophthalmic USA, Inc. | 1996 | — |
| 0 (this device) | K990064 | DI-Rhex Ophthalmic Diathermy System | Ophthalmic Technologies, Inc. | 1999 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 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 |
|---|---|---|---|
| * | K962135 | D.O.R.C. Microdiathermy SystemSummary page 1…on name: Radio Frequency, Electrosurgical, Cautery Apparatus (3) Equivalent legally-marketed devices. 1. Dutch Ophthalmic USA system, "D.O.R.C. Microdiathermy System," K962135. 2. Surgitron Diathermy System, K980170 (4) Description The system consists of a central control unit that supplies radio freque… | 1996 |
| * | K980170 | SurgitronSummary page 1…l, Cautery Apparatus (3) Equivalent legally-marketed devices. 1. Dutch Ophthalmic USA system, "D.O.R.C. Microdiathermy System," K962135. 2. Surgitron Diathermy System, K980170 (4) Description The system consists of a central control unit that supplies radio frequency energy to a handpiece. The unit can… | 1998 |
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?
- None of the 2 ancestors has a recall.
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 OTI Di-rhex Ophthalmic Diathermy Unit is intended to be used for producing
haemeostasis in the anterior and posterior segment of the eye, for conjunctival welding
(coaptation), retinal coagulation using endodiathermy tips, end for cutting in ophthalmic
surgery, using a high frequency current applied by a bipolar probe.
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/K990064 · printed Nov 4, 2026
Cite this page
510(k) Report. “K990064: DI-Rhex Ophthalmic Diathermy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K990064
Report an extraction error
Are you the manufacturer?
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