510(k) · Cleared
ClearedCatarhex 3
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Oertli Instrumente AG · HQC Unit, Phacofragmentation
Cleared on Aug 12, 2014 as substantially equivalent to K081877 (Dutch Ophthalmic Research Center International BV, 2009) and 2 other predicates after a 265-day review. Its family tree reaches back 6 generations to 1985. 1 later device descends from it.
- Decided
- Aug 12, 2014
- Review
- 265 days
- Class
- Class II
- Product code
- HQC
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K844373 (1985). 20 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK844373 O.M.S. Ultra-PhacoOptical Micro Systems, Inc. · 1985
- 5 generations backK981116 Sovereign Cataract Extraction SystemAllergan, Inc. · 1998 · Recalled
- 4 generations backK021566 InfinitiAlcon Laboratories, Inc. · 2002 · Recalled
- 3 generations backK063331 Bausch & Lomb NGX Microsurgical SystemBausch & Lomb, Inc. · 2006 · Recalled
- 2 generations backK082473 Bausch & Lomb Stellaris Microsurgical SystemBausch & Lomb, Inc. · 2009 · Recalled
- 1 generation backK101325 Stellaris PC Vision Enhancement SystemBausch & Lomb, Inc. · 2010 · Recalled
- This deviceK133562 Catarhex 3Oertli Instrumente AG · 2014
- Descendant · cites it directly · 0 of its ownK233398 Faros Surgical SystemOertli Instrumente AG · 2024
Most influential descendants
Showing 1 of 1 · See all- K233398Faros Surgical SystemOertli Instrumente AG · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K844373 | O.M.S. Ultra-Phaco | Optical Micro Systems, Inc. | 1985 | — |
| −5 | K981116 | Sovereign Cataract Extraction System | Allergan, Inc. | 1998 | 1 |
| −4 | K021566 | Infiniti | Alcon Laboratories, Inc. | 2002 | 3 |
| −3 | K063331 | Bausch & Lomb NGX Microsurgical System | Bausch & Lomb, Inc. | 2006 | 12 |
| −2 | K082473 | Bausch & Lomb Stellaris Microsurgical System | Bausch & Lomb, Inc. | 2009 | 4 |
| −1 | K101325 | Stellaris PC Vision Enhancement System | Bausch & Lomb, Inc. | 2010 | 1 |
| 0 (this device) | K133562 | Catarhex 3 | Oertli Instrumente AG | 2014 | — |
| +1 | K233398 | Faros Surgical System | Oertli Instrumente AG | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 3 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 HQC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new HQC device
- #1 K261264 Stellaris Elite™ vision enhancement system…score 13.4 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K081877 | Associate 2500 Dual and Compact SystemsSummary page 5…ubstantially equivalent, for the purpose of this 510(k), to the following predicate devices. 510(k) Number Clearance Date Device Description K081877 01/05/2009 ASSOCIATE 2500 DUAL AND… | 2009 |
| * | K101325 | Stellaris PC Vision Enhancement SystemSummary page 5…ASSOCIATE 2500 DUAL AND COMPACT SYSTEMS K101325 08/17/2010 STELLARIS PC VISION ENH… | 2010 |
| * | K001498 | The Fugo BladeSummary page 5…STELLARIS PC VISION ENHANCEMENT SYSTEM K001498 10/08/2004 THE FUGO BLADE Device Description The CataRhex 3 is medical electrical equipme… | 2000 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K233398 | Faros Surgical System | 2024 | 0 |
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?
- The line of descent spans 29 years and passes through 5 companies; a new generation was cleared every 4.1 years on median.
- 11 of the 20 ancestors have a recall of any class.
- Of its descendants, K233398 (Oertli Instrumente AG, 2024) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K081877.
How does its category compare?
All HQC devicesHQC Unit, Phacofragmentation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · HQC
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HQC
267in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HQC
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HQC
1,799in 2025
MAUDE reports naming product code HQC, 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 | 341 |
| 2008 | 4 | 162 | 1 | 444 |
| 2009 | 5 | 131 | 1 | 540 |
| 2010 | 3 | 142 | 22 | 2,431 |
| 2011 | 5 | 129 | 4 | 1,802 |
| 2012 | 5 | 125 | 1 | 2,277 |
| 2013 | 0 | — | 0 | 2,772 |
| 2014 | 4 | 135 | 1 | 2,740 |
| 2015 | 3 | 124 | 0 | 3,355 |
| 2016 | 1 | — | 0 | 3,374 |
| 2017 | 3 | 214 | 0 | 2,781 |
| 2018 | 0 | — | 2 | 2,416 |
| 2019 | 4 | 126 | 0 | 2,287 |
| 2020 | 4 | 227 | 0 | 1,217 |
| 2021 | 1 | — | 0 | 1,673 |
| 2022 | 4 | 245 | 5 | 1,907 |
| 2023 | 1 | — | 1 | 1,799 |
| 2024 | 5 | 197 | 0 | 2,120 |
| 2025 | 3 | 267 | 1 | 1,799 |
| 2026 | 3 | 115 | 0 | — |
What is it indicated for?
The CataRhex 3 is used for surgical interventions in the anterior eye segment.
Irrigation and aspiration (I/A function)
Ultrasound phaco (PHACO function)
Bipolar diathermy for hemostasis and welding of the conjunctiva (DIA function)
Diathermic capsulotomy (CAPS function)
Operation of a vitrectomy instrument (VIT function)
The device may only be used with instruments recommended and supplied by Oertli Instrumente AG.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133562 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133562: Catarhex 3.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133562
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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