510(k) · Cleared
ClearedPHAKOS Disposable Retinal Cryo Probe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Phakos · HRN Unit, Cryophthalmic, Ac-Powered
Cleared on May 3, 2017 as substantially equivalent to K062412 (Keeler Instruments, Inc., 2006) and 1 other predicate after a 215-day review. Its family tree reaches back 2 generations to 1988. 2 later devices descend from it.
- Decided
- May 3, 2017
- Review
- 215 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 deviceK162756 PHAKOS Disposable Retinal Cryo ProbePhakos · 2017
- Descendant · cites it directly · 1 of its ownK180195 Frigitronics adapterPhakos · 2018
- Descendant · cites it directly · 0 of its ownK200911 MIRA AdapterPhakos · 2020
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) | K162756 | PHAKOS Disposable Retinal Cryo Probe | Phakos | 2017 | — |
| +1 | K180195 | Frigitronics adapter | Phakos | 2018 | — |
| +1 | K200911 | MIRA Adapter | Phakos | 2020 | — |
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 |
|---|---|---|
| 2018 | 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 4…n 21 CFR section 886.4170 Device Panel Ophthalmic Primary Predicate Keeler Cryomaster Probes – Keeler Instruments, Inc. (K062412 & K112093) Device The PHAKOS Disposable Retinal Cryo Probe is a single use item used with… | 2006 |
| * | K112093 | Cryomatic Cryo Console, Disposable Cryo Probe, Disposable Probe AdapterSummary page 4…21 CFR section 886.4170 Device Panel Ophthalmic Primary Predicate Keeler Cryomaster Probes – Keeler Instruments, Inc. (K062412 & K112093) Device The PHAKOS Disposable Retinal Cryo Probe is a single use item used with… | 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?
How does its category compare?
All HRN devicesHRN Unit, Cryophthalmic, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 PHAKOS Disposable Retinal Cryo Probe is for use in ophthalmic surgery in cryopexy for retinal detachment, cyclo destructive procedures in refractory glaucoma, extraction of fragments within the vitreous cavity, cataract extraction, and cryo destruction of lash follicles for trichiasis.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K162756 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162756: PHAKOS Disposable Retinal Cryo Probe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162756
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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