510(k) · Cleared
ClearedFrigitronics adapter
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 Mar 16, 2018 as substantially equivalent to K162756 (Phakos, 2017) after a 51-day review. Its family tree reaches back 3 generations to 1988. 1 later device descends from it.
- Decided
- Mar 16, 2018
- Review
- 51 days
- Class
- Class II
- Product code
- HRN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K874555 (1988). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK874555 Keeler Acu 22XT Ophthalmic Cryo UnitKeeler Instruments, Inc. · 1988
- 2 generations backK062412 CryomaticKeeler Instruments, Inc. · 2006
- 1 generation backK162756 PHAKOS Disposable Retinal Cryo ProbePhakos · 2017
- This deviceK180195 Frigitronics adapterPhakos · 2018
- Descendant · cites it directly · 0 of its ownK200911 MIRA AdapterPhakos · 2020
Most influential descendants
Showing 1 of 1 · See all- K200911MIRA AdapterPhakos · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K874555 | Keeler Acu 22XT Ophthalmic Cryo Unit | Keeler Instruments, Inc. | 1988 | — |
| −2 | K062412 | Cryomatic | Keeler Instruments, Inc. | 2006 | — |
| −1 | K162756 | PHAKOS Disposable Retinal Cryo Probe | Phakos | 2017 | — |
| 0 (this device) | 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 |
|---|---|---|
| 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 0.4 · 4 generations · no Class I recall
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K162756 | PHAKOS Disposable Retinal Cryo ProbeSummary page 4…HRN CFR Section 21 CFR section 886.4170 Device Panel Ophthalmic Primary Predicate PHAKOS Disposable Retinal Cryo Probe (K162756) Device The cryoprobe adapter is a mechanical accessory used to adapt the PHAKOS Disposable… | 2017 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K200911 | MIRA Adapter | 2020 | 0 |
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 30 years and passes through 2 companies; a new generation was cleared every 10.5 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K200911 (Phakos, 2020) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K162756.
How does its category compare?
All HRN devicesHRN Unit, Cryophthalmic, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 and Accessories 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 as stated in the FDA summary.
https://510kreport.com/device/K180195 · printed Nov 4, 2026
Cite this page
510(k) Report. “K180195: Frigitronics adapter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K180195
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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