510(k) · Cleared
ClearedCryomatic
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 Nov 6, 2006 as substantially equivalent to K992954 (Keeler Instruments, Inc., 1999) and 1 other predicate after an 81-day review. Its family tree reaches back 1 generation to 1988. 6 later devices descend from it.
- Decided
- Nov 6, 2006
- Review
- 81 days
- Class
- Class II
- Product code
- HRN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K874555 (1988). 2 ancestors in all. 6 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK874555 Keeler Acu 22XT Ophthalmic Cryo UnitKeeler Instruments, Inc. · 1988
- This deviceK062412 CryomaticKeeler Instruments, Inc. · 2006
- 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 |
|---|---|---|---|---|---|
| −1 | K874555 | Keeler Acu 22XT Ophthalmic Cryo Unit | Keeler Instruments, Inc. | 1988 | — |
| 0 (this device) | K062412 | Cryomatic | Keeler Instruments, Inc. | 2006 | — |
| +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 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
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), 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 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? (2)
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 |
|---|---|---|---|
| * | K992954 | Keeler Cryo Master & ProbesSummary page 1…nd assigned the Product Code 86HRN 3 Predicate Devices The components of the Cryomatic System are substantially equivalent to the following legally marketed devices: K992954 Keeler Cryomaster and Probes K874555 Keeler ACU 22 XT Ophthalmic Cryo unit. This statement is based on the si… | 1999 |
| * | K874555 | Keeler Acu 22XT Ophthalmic Cryo UnitSummary page 1…Devices The components of the Cryomatic System are substantially equivalent to the following legally marketed devices: K992954 Keeler Cryomaster and Probes K874555 Keeler ACU 22 XT Ophthalmic Cryo unit. This statement is based on the similarity of the subject device to the predicate… | 1988 |
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?
How does its category compare?
All HRN devicesHRN Unit, Cryophthalmic, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 | — |
What is it indicated for?
The Keeler Cryomatic System and probes are for use in ophthalmic surgery in cryopexy of retinal detachment, cyclo destructive procedures in refractory glaucoma, extraction of follicles fragments within the vitreous cavity, cataract extraction, cryo destruction of lash follicles for trichiasis, and treatment of retinopathy of prematurity (ROP)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062412 · printed Nov 5, 2026
Cite this page
510(k) Report. “K062412: Cryomatic.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K062412
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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