510(k) · Cleared
ClearedCryomatic Mkii Console, Cryomatic Mkii Probes, Disposable Cryo Probes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Keeler, Ltd. · HRN Unit, Cryophthalmic, Ac-Powered
Cleared on Dec 23, 2013 as substantially equivalent to K062412 (Keeler Instruments, Inc., 2006) and 1 other predicate after a 188-day review. Its family tree reaches back 2 generations to 1988. 2 later devices descend from it.
- Decided
- Dec 23, 2013
- Review
- 188 days
- Class
- Class II
- Product code
- HRN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K874555 (1988). 4 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK874555 Keeler Acu 22XT Ophthalmic Cryo UnitKeeler Instruments, Inc. · 1988
- 1 generation backK062412 CryomaticKeeler Instruments, Inc. · 2006
- This deviceK131787 Cryomatic Mkii Console, Cryomatic Mkii Probes, Disposable Cryo ProbesKeeler, Ltd. · 2013
- Descendant · cites it directly · 0 of its ownK202038 CryoTreQVitreQ BV · 2020 · Recalled
- Descendant · cites it directly · 0 of its ownK160591 D.O.R.C. Disposable Cryo ProbeDutch Ophthalmic Research Center International BV · 2017
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K874555 | Keeler Acu 22XT Ophthalmic Cryo Unit | Keeler Instruments, Inc. | 1988 | — |
| −1 | K062412 | Cryomatic | Keeler Instruments, Inc. | 2006 | — |
| 0 (this device) | K131787 | Cryomatic Mkii Console, Cryomatic Mkii Probes, Disposable Cryo Probes | Keeler, Ltd. | 2013 | — |
| +1 | K202038 | CryoTreQ | VitreQ BV | 2020 | 1 |
| +1 | K160591 | D.O.R.C. Disposable Cryo Probe | Dutch Ophthalmic Research Center International BV | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2020 | 1 | 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 |
|---|---|---|---|
| * | K062412 | CryomaticSummary page 3…eler Cryomatic System & Probes (including the disposable probe) is the same as originally cleared under the original 51 0(k) premarket notifications (K062412 &K1 12093). 6. Materials Biocompatibility With respect to materials that come into direct contact intentionally… | 2006 |
| * | K112093 | Cryomatic Cryo Console, Disposable Cryo Probe, Disposable Probe AdapterSummary page 1…886.4170 Device Regulatory Class: 11 Product Code: HRN Review Panel: Ophthalmic 510(k) Number: K(062412 & K1 12093 3. Proposed Modification The proposed modification described in this Special 51 0(k) covers the simplification of… | 2011 |
What descends from it? (2)
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?
- The line of descent spans 25 years and passes through 2 companies; a new generation was cleared every 18.8 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K202038 (VitreQ BV, 2020) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K062412.
How does its category compare?
All HRN devicesHRN Unit, Cryophthalmic, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 | — |
What is it indicated for?
The Keeler Cryomatic System and probes are for use in ophthalmic surgery such as cryopexy for retinal detachment, cyclo destructive procedures Inrefractory glaucoma, extraction of 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/K131787 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131787: Cryomatic Mkii Console, Cryomatic Mkii Probes, Disposable Cryo Probes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131787
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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