510(k) · Cleared
ClearedCMS Urethral Warmer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cryomedical Sciences, Inc. · GEH Unit, Cryosurgical, Accessories
Cleared on Oct 24, 1995 after a 123-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.
- Decided
- Oct 24, 1995
- Review
- 123 days
- Class
- Class II
- Product code
- GEH
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK952895 CMS Urethral WarmerCryomedical Sciences, Inc. · 1995
- Descendant · cites it directly · 2 of its ownK963970 Endocare Cryocare Cryosurgical System Urethral Warming SystemEndocare, Inc. · 1997
- Descendant · 2 generations on · 0 of its ownK211149 Urethral Warming Catheter KitVarian Medical Systems, Inc. · 2022
- Descendant · 2 generations on · 0 of its ownK090978 UC-Care Warming SystemUC-CARE, Ltd. · 2009
- Descendant · cites it directly · 0 of its ownK955011 Candela HCS 2000 Uretheral Warmer CatheterCandela Laser Corp. · 1996
Most influential descendants
Showing 4 of 4 · See all- K963970Endocare Cryocare Cryosurgical System Urethral Warming SystemEndocare, Inc. · 1997 · cites it directly2descendants
- K211149Urethral Warming Catheter KitVarian Medical Systems, Inc. · 2022 · 2 generations on0descendants
- K090978UC-Care Warming SystemUC-CARE, Ltd. · 2009 · 2 generations on0descendants
- K955011Candela HCS 2000 Uretheral Warmer CatheterCandela Laser Corp. · 1996 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K952895 | CMS Urethral Warmer | Cryomedical Sciences, Inc. | 1995 | — |
| +1 | K963970 | Endocare Cryocare Cryosurgical System Urethral Warming System | Endocare, Inc. | 1997 | — |
| +2 | K211149 | Urethral Warming Catheter Kit | Varian Medical Systems, Inc. | 2022 | — |
| +2 | K090978 | UC-Care Warming System | UC-CARE, Ltd. | 2009 | — |
| +1 | K955011 | Candela HCS 2000 Uretheral Warmer Catheter | Candela Laser Corp. | 1996 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 2009 | 1 | 0 |
| 2022 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GEH? 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 GEH device
- #1 K211099 Freeze’n Clear Skin Clinic Warts & Tagsscore 25.4 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (4)
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, K963970 (Endocare, Inc., 1997) has gone furthest, with 2 descendants of its own.
How does its category compare?
All GEH devicesGEH Unit, Cryosurgical, Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GEH
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEH
77in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEH
2in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GEH
171in 2025
MAUDE reports naming product code GEH, 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 | 6 | 71 | 3 | 23 |
| 2008 | 1 | — | 2 | 29 |
| 2009 | 4 | 121 | 13 | 21 |
| 2010 | 4 | 86 | 4 | 173 |
| 2011 | 7 | 91 | 0 | 61 |
| 2012 | 4 | 96 | 3 | 91 |
| 2013 | 4 | 76 | 0 | 91 |
| 2014 | 6 | 42 | 2 | 57 |
| 2015 | 11 | 72 | 0 | 97 |
| 2016 | 15 | 60 | 0 | 143 |
| 2017 | 12 | 83 | 0 | 216 |
| 2018 | 6 | 42 | 1 | 208 |
| 2019 | 6 | 115 | 1 | 455 |
| 2020 | 8 | 113 | 37 | 277 |
| 2021 | 6 | 206 | 0 | 213 |
| 2022 | 6 | 56 | 0 | 230 |
| 2023 | 8 | 136 | 2 | 164 |
| 2024 | 9 | 85 | 0 | 141 |
| 2025 | 10 | 77 | 0 | 171 |
| 2026 | 8 | 148 | 2 | — |
https://510kreport.com/device/K952895 · printed Nov 5, 2026
Cite this page
510(k) Report. “K952895: CMS Urethral Warmer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K952895
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026