510(k) · Cleared
ClearedMIRA 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 Jun 2, 2020 as substantially equivalent to K162756 (Phakos, 2017) and 1 other predicate after a 57-day review. Its family tree reaches back 4 generations to 1988.
- Decided
- Jun 2, 2020
- Review
- 57 days
- Class
- Class II
- Product code
- HRN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K874555 (1988). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK874555 Keeler Acu 22XT Ophthalmic Cryo UnitKeeler Instruments, Inc. · 1988
- 3 generations backK062412 CryomaticKeeler Instruments, Inc. · 2006
- 2 generations backK162756 PHAKOS Disposable Retinal Cryo ProbePhakos · 2017
- 1 generation backK180195 Frigitronics adapterPhakos · 2018
- This deviceK200911 MIRA AdapterPhakos · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K874555 | Keeler Acu 22XT Ophthalmic Cryo Unit | Keeler Instruments, Inc. | 1988 | — |
| −3 | K062412 | Cryomatic | Keeler Instruments, Inc. | 2006 | — |
| −2 | K162756 | PHAKOS Disposable Retinal Cryo Probe | Phakos | 2017 | — |
| −1 | K180195 | Frigitronics adapter | Phakos | 2018 | — |
| 0 (this device) | K200911 | MIRA Adapter | Phakos | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2011 | 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.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
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 |
|---|---|---|---|
| * | 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 Reference Predicates FRIGITRONICS ADAPTER (K180195) The cryoprobe ADAPTER is a mechanic… | 2017 |
| * | K180195 | Frigitronics adapterSummary page 4…0 Device Panel Ophthalmic Primary Predicate PHAKOS Disposable Retinal Cryo Probe (K162756) Device Reference Predicates FRIGITRONICS ADAPTER (K180195) The cryoprobe ADAPTER is a mechanical accessory used to adapt the PHAKOS… | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
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 32 years and passes through 2 companies; a new generation was cleared every 10.5 years on median.
- None of the 6 ancestors has a recall.
- 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. 2020, 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/K200911 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200911: MIRA Adapter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200911
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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