510(k) · Cleared
ClearedD.O.R.C. Disposable Cryo Probe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dutch Ophthalmic Research Center International BV · HRN Unit, Cryophthalmic, Ac-Powered
Cleared on Jan 23, 2017 as substantially equivalent to K012821 (Dutch Ophthalmic USA, Inc., 2001) and 1 other predicate after a 328-day review. Its family tree reaches back 3 generations to 1988.
- Decided
- Jan 23, 2017
- Review
- 328 days
- Class
- Class II
- Product code
- HRN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K874555 (1988). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK874555 Keeler Acu 22XT Ophthalmic Cryo UnitKeeler Instruments, Inc. · 1988
- 2 generations backK062412 CryomaticKeeler Instruments, Inc. · 2006
- 1 generation backK131787 Cryomatic Mkii Console, Cryomatic Mkii Probes, Disposable Cryo ProbesKeeler, Ltd. · 2013
- This deviceK160591 D.O.R.C. Disposable Cryo ProbeDutch Ophthalmic Research Center International BV · 2017
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 | K131787 | Cryomatic Mkii Console, Cryomatic Mkii Probes, Disposable Cryo Probes | Keeler, Ltd. | 2013 | — |
| 0 (this device) | 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 |
|---|---|---|
| 1994 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 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.
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 |
|---|---|---|---|
| * | K012821 | D.O.R.C. Cryostar Cryosurgical SystemSummary page 4…oduct Code HRN) The following regulations are applicable for this 510(k): • 21 CFR 886.4170 Cryophthalmic unit Predicate Devices 510(k) Number Device K012821 Cryostar Cryosurgical System Reusable Cryo Probe (D.O.R.C.) K131787 Cryomatic Disposable Cryo Probe… | 2001 |
| * | K131787 | Cryomatic Mkii Console, Cryomatic Mkii Probes, Disposable Cryo ProbesSummary page 4…21 CFR 886.4170 Cryophthalmic unit Predicate Devices 510(k) Number Device K012821 Cryostar Cryosurgical System Reusable Cryo Probe (D.O.R.C.) K131787 Cryomatic Disposable Cryo Probes (Keeler Ltd.) Device Description The D.O.R.C. Disposable Cryo Probe is a single-… | 2013 |
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 29 years and passes through 3 companies; a new generation was cleared every 7.1 years on median.
- None of the 7 ancestors has a recall.
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 D.O.R.C. Disposable Cryo Probe is intended for use in combination with the Cryostar Cryosurgical System to perform ophthalmic surgery of the posterior or anterior segments including cryopexy for retinal detachment, glaucoma, cataract extraction, trichiasis, and retionopathy of prematurity.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160591 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160591: D.O.R.C. Disposable 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/K160591
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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