510(k) · Cleared
ClearedPhaco 20/20 System I
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Innovative Medical Systems, Inc. · HQC Unit, Phacofragmentation
Cleared on Feb 24, 1992 after an 81-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 7 later devices descend from it.
- Decided
- Feb 24, 1992
- Review
- 81 days
- Class
- Class II
- Product code
- HQC
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 1 citing it directly.
- This deviceK915457 Phaco 20/20 System IInnovative Medical Systems, Inc. · 1992
- Descendant · cites it directly · 6 of its ownK981103 Turbosonics Limited Reuse Ultrasonic TipAlcon Laboratories · 1998
- Descendant · 2 generations on · 4 of its ownK030179 Medisiss Phacoemulsification Tips/NeedlesSurgical Instruments Service and Savings, Inc. · 2003 · Recalled
- Descendant · 3 generations on · 3 of its ownK041841 PachycamOculus Optikgerate GmbH · 2005
- Descendant · 4 generations on · 1 of its ownK073508 ParkoneOculus Optikgerate GmbH · 2008
- Descendant · 5 generations on · 0 of its ownK202989 Myopia MasterOculus Optikgeräte GmbH · 2021 · Recalled
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K981103Turbosonics Limited Reuse Ultrasonic TipAlcon Laboratories · 1998 · cites it directly6descendants
- K030179Medisiss Phacoemulsification Tips/NeedlesSurgical Instruments Service and Savings, Inc. · 2003 · 2 generations on4descendants
- K041841PachycamOculus Optikgerate GmbH · 2005 · 3 generations on3descendants
- K073508ParkoneOculus Optikgerate GmbH · 2008 · 4 generations on1descendant
- K202989Myopia MasterOculus Optikgeräte GmbH · 2021 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K915457 | Phaco 20/20 System I | Innovative Medical Systems, Inc. | 1992 | — |
| +1 | K981103 | Turbosonics Limited Reuse Ultrasonic Tip | Alcon Laboratories | 1998 | — |
| +2 | K030179 | Medisiss Phacoemulsification Tips/Needles | Surgical Instruments Service and Savings, Inc. | 2003 | 1 |
| +3 | K041841 | Pachycam | Oculus Optikgerate GmbH | 2005 | — |
| +4 | K073508 | Parkone | Oculus Optikgerate GmbH | 2008 | — |
| +5 | K202989 | Myopia Master | Oculus Optikgeräte GmbH | 2021 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
| 2012 | 1 | 0 |
| 2021 | 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K981103 | Turbosonics Limited Reuse Ultrasonic Tip | 1998 | 6 |
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, K981103 (Alcon Laboratories, 1998) has gone furthest, with 6 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/K915457 · printed Nov 4, 2026
Cite this page
510(k) Report. “K915457: Phaco 20/20 System I.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K915457
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