510(k) · Cleared

Cleared

Cryocare Surgical System

K003811510(k) TraditionalCleared Oct 11, 2001304-day reviewClass II21 CFR 878.4350

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Endocare, Inc. · GEH Unit, Cryosurgical, Accessories

Cleared on Oct 11, 2001 after a 304-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 39 later devices descend from it.

Decided: Oct 11, 2001
Review: 304 days
Class: Class II
Product code: GEH
Recalls: None
Predicates: 0

39 later devices descend from it, 3 citing it directly.

This deviceK003811 Cryocare Surgical SystemEndocare, Inc. · 2001
Descendant · cites it directly · 31 of its ownK020605 Sanarus Visica Treatment SystemSanarus Medical, Inc. · 2002
Descendant · 2 generations on · 30 of its ownK021211 Modification to Sanarus Visica Treatment SystemSanarus Medical, Inc. · 2002
Descendant · 3 generations on · 29 of its ownK022314 Sanarus Visica Treatment SystemSanarus Medical, Inc. · 2002 · Recalled
Descendant · 4 generations on · 28 of its ownK052861 Modification to:Sanarus Visica Treatment System , Models VS2000Sanarus Medical, Inc. · 2005
Descendant · 4 generations on · 27 of its ownK061510 Sanarus Visica Treatment SystemSanarus Medical, Inc. · 2006

Showing 5 of 39 descendants. See all descendants

Descendants cleared per year

2002high 6 (2016) · low 0 (2003)2026

Most influential descendants

Showing 5 of 39 · See all

K020605Sanarus Visica Treatment SystemSanarus Medical, Inc. · 2002 · cites it directly31descendants
K021211Modification to Sanarus Visica Treatment SystemSanarus Medical, Inc. · 2002 · 2 generations on30descendants
K022314Sanarus Visica Treatment SystemSanarus Medical, Inc. · 2002 · 3 generations on29descendants
K052861Modification to:Sanarus Visica Treatment System , Models VS2000Sanarus Medical, Inc. · 2005 · 4 generations on28descendants
K061510Sanarus Visica Treatment SystemSanarus Medical, Inc. · 2006 · 4 generations on27descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K003811	Cryocare Surgical System	Endocare, Inc.	2001	—
+1	K020605	Sanarus Visica Treatment System	Sanarus Medical, Inc.	2002	—
+2	K021211	Modification to Sanarus Visica Treatment System	Sanarus Medical, Inc.	2002	—
+3	K022314	Sanarus Visica Treatment System	Sanarus Medical, Inc.	2002	1
+4	K052861	Modification to:Sanarus Visica Treatment System , Models VS2000	Sanarus Medical, Inc.	2005	—
+4	K061510	Sanarus Visica Treatment System	Sanarus Medical, Inc.	2006	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	3	0
2005	1	0
2006	1	0
2007	2	0
2010	1	0
2014	1	0
2015	3	0
2016	6	0
2017	5	0
2018	1	0
2019	2	0
2020	3	0
2021	1	0
2022	2	0
2023	2	0
2024	2	0
2025	2	0
2026	1	0

FIG. 1 — Lineage of K003811, 2001–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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.

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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? (39)

See all 39

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K020605	Sanarus Visica Treatment System	Sanarus Medical, Inc.	2002	31
K153489	Cryocare CS Surgical System	Healthtronics	2016	5
K070353	Kelsey Intersitital Laser Therapy System	Kelsey, Inc.	2007	1

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, K020605 (Sanarus Medical, Inc., 2002) has gone furthest, with 31 descendants of its own.

How does its category compare?

All GEH devices

GEH Unit, Cryosurgical, Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GEH

10in 2025

2007high 15 (2016) · low 1 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GEH

77in 2025

2007high 206 (2021) · low 42 (2014)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GEH

2in 2023

2007high 37 (2020) · low 0 (2011)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · GEH

171in 2025

2007high 455 (2019) · low 21 (2009)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/K003811 · printed Nov 6, 2026

Cite this page

510(k) Report. “K003811: Cryocare Surgical System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K003811

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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