510(k) · Cleared
ClearedCryomatic Cryo Console, Disposable Cryo Probe, Disposable Probe Adapter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Keeler Instruments, Inc. · HRN Unit, Cryophthalmic, Ac-Powered
Cleared on Dec 8, 2011 after a 139-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 later devices descend from it.
- Decided
- Dec 8, 2011
- Review
- 139 days
- Class
- Class II
- Product code
- HRN
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 2 citing it directly.
- This deviceK112093 Cryomatic Cryo Console, Disposable Cryo Probe, Disposable Probe…Keeler Instruments, Inc. · 2011
- Descendant · cites it directly · 2 of its ownK162756 PHAKOS Disposable Retinal Cryo ProbePhakos · 2017
- Descendant · cites it directly · 2 of its ownK131787 Cryomatic Mkii Console, Cryomatic Mkii Probes, Disposable Cryo ProbesKeeler, Ltd. · 2013
- Descendant · 2 generations on · 1 of its ownK180195 Frigitronics adapterPhakos · 2018
- Descendant · 2 generations on · 0 of its ownK202038 CryoTreQVitreQ BV · 2020 · Recalled
- Descendant · 2 generations on · 0 of its ownK200911 MIRA AdapterPhakos · 2020
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K162756PHAKOS Disposable Retinal Cryo ProbePhakos · 2017 · cites it directly2descendants
- K131787Cryomatic Mkii Console, Cryomatic Mkii Probes, Disposable Cryo ProbesKeeler, Ltd. · 2013 · cites it directly2descendants
- K180195Frigitronics adapterPhakos · 2018 · 2 generations on1descendant
- K202038CryoTreQVitreQ BV · 2020 · 2 generations on0descendants
- K200911MIRA AdapterPhakos · 2020 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K112093 | Cryomatic Cryo Console, Disposable Cryo Probe, Disposable Probe Adapter | Keeler Instruments, Inc. | 2011 | — |
| +1 | K162756 | PHAKOS Disposable Retinal Cryo Probe | Phakos | 2017 | — |
| +1 | K131787 | Cryomatic Mkii Console, Cryomatic Mkii Probes, Disposable Cryo Probes | Keeler, Ltd. | 2013 | — |
| +2 | K180195 | Frigitronics adapter | Phakos | 2018 | — |
| +2 | K202038 | CryoTreQ | VitreQ BV | 2020 | 1 |
| +2 | K200911 | MIRA Adapter | Phakos | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 HRN? 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 HRN device
- #1 K200911 MIRA Adapterscore 0.3 · 4 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? (6)
2 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, K162756 (Phakos, 2017) has gone furthest, with 2 descendants of its own.
How does its category compare?
All HRN devicesHRN Unit, Cryophthalmic, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · HRN
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · HRN
Too few HRN 510(k)s in any year since 2007 to give a median.
Recalls per year · HRN
No recall names HRN since 2007.
Adverse event reports per year · HRN
1in 2019
MAUDE reports naming product code HRN, 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 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 2 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 2 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 1 |
| 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/K112093 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112093: Cryomatic Cryo Console, Disposable Cryo Probe, Disposable Probe Adapter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112093
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026