510(k) · Cleared
ClearedEndocare Cryotherapy System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cytocare, Inc. · GEH Unit, Cryosurgical, Accessories
Cleared on Jan 19, 1995 after a 252-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 116 later devices descend from it.
- Decided
- Jan 19, 1995
- Review
- 252 days
- Class
- Class II
- Product code
- GEH
- Recalls
- None
- Predicates
- 0
116 later devices descend from it, 2 citing it directly.
- This deviceK942299 Endocare Cryotherapy SystemCytocare, Inc. · 1995
- Descendant · cites it directly · 115 of its ownK963826 Endocare Crycare Cryosurgical SystemEndocare, Inc. · 1996
- Descendant · cites it directly · 94 of its ownK973686 Endocare Cryocare Cryosurgical SystemEndocare, Inc. · 1997
- Descendant · 2 generations on · 93 of its ownK980110 Endocre Cryocare Cryosurgical SystemEndocare, Inc. · 1998
- Descendant · 3 generations on · 92 of its ownK011722 Atricure Bipolar Coagulation SystemAtriCure, Inc. · 2001
- Descendant · 4 generations on · 90 of its ownK020919 Atricure Bipolar System, Models ASU1, ASU2, ASU3, LHP1, LHP2, RHP1AtriCure, Inc. · 2002
Showing 5 of 116 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 116 · See all- K963826Endocare Crycare Cryosurgical SystemEndocare, Inc. · 1996 · cites it directly115descendants
- K973686Endocare Cryocare Cryosurgical SystemEndocare, Inc. · 1997 · cites it directly94descendants
- K980110Endocre Cryocare Cryosurgical SystemEndocare, Inc. · 1998 · 2 generations on93descendants
- K011722Atricure Bipolar Coagulation SystemAtriCure, Inc. · 2001 · 3 generations on92descendants
- K020919Atricure Bipolar System, Models ASU1, ASU2, ASU3, LHP1, LHP2, RHP1AtriCure, Inc. · 2002 · 4 generations on90descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K942299 | Endocare Cryotherapy System | Cytocare, Inc. | 1995 | — |
| +1 | K963826 | Endocare Crycare Cryosurgical System | Endocare, Inc. | 1996 | — |
| +1 | K973686 | Endocare Cryocare Cryosurgical System | Endocare, Inc. | 1997 | — |
| +2 | K980110 | Endocre Cryocare Cryosurgical System | Endocare, Inc. | 1998 | — |
| +3 | K011722 | Atricure Bipolar Coagulation System | AtriCure, Inc. | 2001 | — |
| +4 | K020919 | Atricure Bipolar System, Models ASU1, ASU2, ASU3, LHP1, LHP2, RHP1 | AtriCure, Inc. | 2002 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 2 | 0 |
| 2006 | 10 | 0 |
| 2007 | 4 | 0 |
| 2008 | 10 | 0 |
| 2009 | 3 | 0 |
| 2010 | 3 | 0 |
| 2011 | 5 | 0 |
| 2012 | 7 | 0 |
| 2013 | 2 | 0 |
| 2014 | 5 | 0 |
| 2015 | 2 | 0 |
| 2016 | 4 | 0 |
| 2017 | 2 | 0 |
| 2018 | 5 | 0 |
| 2019 | 8 | 0 |
| 2020 | 5 | 0 |
| 2021 | 3 | 0 |
| 2022 | 4 | 0 |
| 2023 | 6 | 0 |
| 2024 | 8 | 0 |
| 2025 | 4 | 0 |
| 2026 | 5 | 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (116)
See all 1162 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, K963826 (Endocare, Inc., 1996) has gone furthest, with 115 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/K942299 · printed Nov 4, 2026
Cite this page
510(k) Report. “K942299: Endocare Cryotherapy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K942299
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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