510(k) · Cleared
ClearedO.M.S. Ultra-Phaco
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Optical Micro Systems, Inc. · HQC Unit, Phacofragmentation
Cleared on Dec 19, 1985 after a 401-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 63 later devices descend from it.
- Decided
- Dec 19, 1985
- Review
- 401 days
- Class
- Class II
- Product code
- HQC
- Recalls
- None
- Predicates
- 0
63 later devices descend from it, 2 citing it directly.
- This deviceK844373 O.M.S. Ultra-PhacoOptical Micro Systems, Inc. · 1985
- Descendant · cites it directly · 59 of its ownK981116 Sovereign Cataract Extraction SystemAllergan, Inc. · 1998 · Recalled
- Descendant · 2 generations on · 50 of its ownK021566 InfinitiAlcon Laboratories, Inc. · 2002 · Recalled
- Descendant · 2 generations on · 36 of its ownK063583 Alcon Vision SystemAlcon · 2008 · Recalled
- Descendant · 3 generations on · 24 of its ownK063331 Bausch & Lomb NGX Microsurgical SystemBausch & Lomb, Inc. · 2006 · Recalled
- Descendant · 2 generations on · 22 of its ownK082845 Infiniti Vision System with Ozil IPAlcon Research, Ltd. · 2009
Showing 5 of 63 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 63 · See all- K981116Sovereign Cataract Extraction SystemAllergan, Inc. · 1998 · cites it directly59descendants
- K021566InfinitiAlcon Laboratories, Inc. · 2002 · 2 generations on50descendants
- K063583Alcon Vision SystemAlcon · 2008 · 2 generations on36descendants
- K063331Bausch & Lomb NGX Microsurgical SystemBausch & Lomb, Inc. · 2006 · 3 generations on24descendants
- K082845Infiniti Vision System with Ozil IPAlcon Research, Ltd. · 2009 · 2 generations on22descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K844373 | O.M.S. Ultra-Phaco | Optical Micro Systems, Inc. | 1985 | — |
| +1 | K981116 | Sovereign Cataract Extraction System | Allergan, Inc. | 1998 | 1 |
| +2 | K021566 | Infiniti | Alcon Laboratories, Inc. | 2002 | 3 |
| +2 | K063583 | Alcon Vision System | Alcon | 2008 | 11 |
| +3 | K063331 | Bausch & Lomb NGX Microsurgical System | Bausch & Lomb, Inc. | 2006 | 12 |
| +2 | K082845 | Infiniti Vision System with Ozil IP | Alcon Research, Ltd. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 4 | 0 |
| 2010 | 4 | 0 |
| 2011 | 6 | 0 |
| 2012 | 5 | 0 |
| 2013 | 1 | 0 |
| 2014 | 6 | 0 |
| 2015 | 6 | 0 |
| 2017 | 7 | 0 |
| 2019 | 2 | 0 |
| 2020 | 3 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 1 | 0 |
| 2024 | 5 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (63)
See all 632 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K981116 (Allergan, Inc., 1998) has gone furthest, with 59 descendants of its own.
How does its category compare?
All HQC devicesHQC Unit, Phacofragmentation: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 | — |
https://510kreport.com/device/K844373 · printed Nov 6, 2026
Cite this page
510(k) Report. “K844373: O.M.S. Ultra-Phaco.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K844373
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026