510(k) · Cleared
ClearedCandela HCS 2000 Uretheral Warmer Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Candela Laser Corp. · GEH Unit, Cryosurgical, Accessories
Cleared on Apr 3, 1996 as substantially equivalent to K952895 (Cryomedical Sciences, Inc., 1995) after a 154-day review. Its family tree reaches back 1 generation to 1995.
- Decided
- Apr 3, 1996
- Review
- 154 days
- Class
- Class II
- Product code
- GEH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K952895 (1995). No later device cites it as a predicate yet.
- Root · 1 generation backK952895 CMS Urethral WarmerCryomedical Sciences, Inc. · 1995
- This deviceK955011 Candela HCS 2000 Uretheral Warmer CatheterCandela Laser Corp. · 1996
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K952895 | CMS Urethral Warmer | Cryomedical Sciences, Inc. | 1995 | — |
| 0 (this device) | K955011 | Candela HCS 2000 Uretheral Warmer Catheter | Candela Laser Corp. | 1996 | — |
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 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? (1)
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 |
|---|---|---|---|
| * | K952895 | CMS Urethral Warmer Our OCR of the scanned summary read K952595, FDA’s number for Haemophilus Test Medium (HTM) (Clinical Standards Laboratories, Inc.), decided Apr 10, 1996, after this device. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Cryomedical Sciences, Inc.’s CMS Urethral Warmer”. | 1995 |
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?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K952895.
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 | — |
What is it indicated for?
The Candela HCS 2000 Urethral Warmer Catheter System is designed to transfer heat into the urethral membrane during cryosurgical ablation of prostatic tissue using the Cryotech LCS 3000 Cryosurgical System.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K955011 · printed Nov 4, 2026
Cite this page
510(k) Report. “K955011: Candela HCS 2000 Uretheral Warmer Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K955011
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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