510(k) · Cleared
Recalled · Class II · 2023CryoTreQ
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
VitreQ BV · HPS Unit, Cryophthalmic
Cleared on Dec 30, 2020 as substantially equivalent to K940373 (Dutch Ophthalmic USA, Inc., 1994) and 1 other predicate after a 160-day review. Its family tree reaches back 3 generations to 1988. It has been recalled once.
- Decided
- Dec 30, 2020
- Review
- 160 days
- Class
- Class II
- Product code
- HPS
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 3 generations to K874555 (1988). 6 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 deviceK202038 CryoTreQVitreQ BV · 2020
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) | K202038 | CryoTreQ | VitreQ BV | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 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 HPS? 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 |
|---|---|---|---|
| * | K940373 | Ophthalmic Cryo UnitSummary page 4…Unit Classification Regulation: 21 CFR 886.4170 Product Code: HPS, Class II Legally Marketed Predicate Primary Predicate Device Name: D.O.R.C. Cryo Unit, 510(k) Number K940373 Secondary Predicate Device Name: Keeler Cryomatic MKII Cryosurgical System, 510(k) Number K131787 Reference Predicate Device Name… | 1994 |
| * | K131787 | Cryomatic Mkii Console, Cryomatic Mkii Probes, Disposable Cryo ProbesSummary page 4…dicate Primary Predicate Device Name: D.O.R.C. Cryo Unit, 510(k) Number K940373 Secondary Predicate Device Name: Keeler Cryomatic MKII Cryosurgical System, 510(k) Number K131787 Reference Predicate Device Name: PHAKOS Disposable Retinal Cryo Probe, 510(k) Number K162756 Description of Subject Device The… | 2013 |
| † | K162756 | PHAKOS Disposable Retinal Cryo Probe | 2017 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 17, 2023 | Class II | Z-1497-2023 | Under Investigation by firm | Device suddenly and forcefully disassembled after cryotherapy, potential for long-term or permanent impairment of a patient or user if a CryoTreq device suddenly or forcefully disassembles during a cryosurgery procedure. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 32 years and passes through 3 companies; a new generation was cleared every 7.1 years on median.
- None of the 6 ancestors has a recall.
- 1 other device also cites its predicate K940373.
How does its category compare?
All HPS devicesHPS Unit, Cryophthalmic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · HPS
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · HPS
Too few HPS 510(k)s in any year since 2007 to give a median.
Recalls per year · HPS
3in 2010
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HPS
5in 2011
MAUDE reports naming product code HPS, 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 | — | 3 | 1 |
| 2011 | 0 | — | 0 | 5 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 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 VitreQ CryoTreQ is indicated for use in ophthalmic surgery such as cryopexy for retinal detachment, cyclodestructive procedures in refractory glaucoma, extraction of fragments within the vitreous cavity, cataract extraction, cryodestruction of lash follicles for trichiasis and the treatment of retinopathy of prematurity (ROP).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K202038 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202038: CryoTreQ.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K202038
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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