510(k) · Cleared
ClearedKeeler Cryo Master & Probes
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 Dec 21, 1999 after a 111-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 8 later devices descend from it.
- Decided
- Dec 21, 1999
- Review
- 111 days
- Class
- Class II
- Product code
- HRN
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 2 citing it directly.
- This deviceK992954 Keeler Cryo Master & ProbesKeeler Instruments, Inc. · 1999
- Descendant · cites it directly · 6 of its ownK062412 CryomaticKeeler Instruments, Inc. · 2006
- Descendant · 2 generations on · 2 of its ownK162756 PHAKOS Disposable Retinal Cryo ProbePhakos · 2017
- Descendant · 2 generations on · 2 of its ownK131787 Cryomatic Mkii Console, Cryomatic Mkii Probes, Disposable Cryo ProbesKeeler, Ltd. · 2013
- Descendant · 3 generations on · 1 of its ownK180195 Frigitronics adapterPhakos · 2018
- Descendant · cites it directly · 1 of its ownK012821 D.O.R.C. Cryostar Cryosurgical SystemDutch Ophthalmic USA, Inc. · 2001
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K062412CryomaticKeeler Instruments, Inc. · 2006 · cites it directly6descendants
- K162756PHAKOS Disposable Retinal Cryo ProbePhakos · 2017 · 2 generations on2descendants
- K131787Cryomatic Mkii Console, Cryomatic Mkii Probes, Disposable Cryo ProbesKeeler, Ltd. · 2013 · 2 generations on2descendants
- K180195Frigitronics adapterPhakos · 2018 · 3 generations on1descendant
- K012821D.O.R.C. Cryostar Cryosurgical SystemDutch Ophthalmic USA, Inc. · 2001 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K992954 | Keeler Cryo Master & Probes | Keeler Instruments, Inc. | 1999 | — |
| +1 | K062412 | Cryomatic | Keeler Instruments, Inc. | 2006 | — |
| +2 | K162756 | PHAKOS Disposable Retinal Cryo Probe | Phakos | 2017 | — |
| +2 | K131787 | Cryomatic Mkii Console, Cryomatic Mkii Probes, Disposable Cryo Probes | Keeler, Ltd. | 2013 | — |
| +3 | K180195 | Frigitronics adapter | Phakos | 2018 | — |
| +1 | K012821 | D.O.R.C. Cryostar Cryosurgical System | Dutch Ophthalmic USA, Inc. | 2001 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2006 | 1 | 0 |
| 2013 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2020 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (8)
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?
- Of its descendants, K062412 (Keeler Instruments, Inc., 2006) has gone furthest, with 6 descendants of its own.
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 CryoMaster & Probes are for use in ophthalmic surgery in cryopexy for retinal detachment, cyclo destructive procedures in refractory glaucoma, extraction of fragments within the vitrcous cavity, cataract extraction, cryo destruction of lash follicles for trichiasis, and treatment of retinopathy of prematurity (ROP).
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K992954 · printed Nov 6, 2026
Cite this page
510(k) Report. “K992954: Keeler Cryo Master & Probes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K992954
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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