510(k) · Cleared
ClearedKeeler Acu 22XT Ophthalmic Cryo Unit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Keeler Instruments, Inc. · HPS Unit, Cryophthalmic
Cleared on Jan 29, 1988 after an 86-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 7 later devices descend from it.
- Decided
- Jan 29, 1988
- Review
- 86 days
- Class
- Class II
- Product code
- HPS
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 1 citing it directly.
- This deviceK874555 Keeler Acu 22XT Ophthalmic Cryo UnitKeeler Instruments, Inc. · 1988
- Descendant · cites it directly · 6 of its ownK062412 CryomaticKeeler Instruments, Inc. · 2006
- Descendant · 2 generations on · 2 of its ownK162756 PHAKOS Disposable Retinal Cryo ProbePhakos · 2017
- Descendant · 2 generations on · 2 of its ownK131787 Cryomatic Mkii Console, Cryomatic Mkii Probes, Disposable Cryo ProbesKeeler, Ltd. · 2013
- Descendant · 3 generations on · 1 of its ownK180195 Frigitronics adapterPhakos · 2018
- Descendant · 3 generations on · 0 of its ownK202038 CryoTreQVitreQ BV · 2020 · Recalled
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K062412CryomaticKeeler Instruments, Inc. · 2006 · cites it directly6descendants
- K162756PHAKOS Disposable Retinal Cryo ProbePhakos · 2017 · 2 generations on2descendants
- K131787Cryomatic Mkii Console, Cryomatic Mkii Probes, Disposable Cryo ProbesKeeler, Ltd. · 2013 · 2 generations on2descendants
- K180195Frigitronics adapterPhakos · 2018 · 3 generations on1descendant
- K202038CryoTreQVitreQ BV · 2020 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K874555 | Keeler Acu 22XT Ophthalmic Cryo Unit | Keeler Instruments, Inc. | 1988 | — |
| +1 | K062412 | Cryomatic | Keeler Instruments, Inc. | 2006 | — |
| +2 | K162756 | PHAKOS Disposable Retinal Cryo Probe | Phakos | 2017 | — |
| +2 | K131787 | Cryomatic Mkii Console, Cryomatic Mkii Probes, Disposable Cryo Probes | Keeler, Ltd. | 2013 | — |
| +3 | K180195 | Frigitronics adapter | Phakos | 2018 | — |
| +3 | K202038 | CryoTreQ | VitreQ BV | 2020 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2013 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2020 | 2 | 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 HPS? 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 HPS device
- #1 K202038 CryoTreQscore -0.8 · 3 generations · no Class I recall
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? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K062412 | Cryomatic | 2006 | 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, K062412 (Keeler Instruments, Inc., 2006) has gone furthest, with 6 descendants of its own.
How does its category compare?
All HPS devicesHPS Unit, Cryophthalmic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HPS
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · HPS
Too few HPS 510(k)s in any year since 2007 to give a median.
Recalls per year · HPS
3in 2010
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HPS
5in 2011
MAUDE reports naming product code HPS, 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 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 3 | 1 |
| 2011 | 0 | — | 0 | 5 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K874555 · printed Nov 4, 2026
Cite this page
510(k) Report. “K874555: Keeler Acu 22XT Ophthalmic Cryo Unit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K874555
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