510(k) · Cleared

Cleared

Wallach Ultra Freeze

K935010510(k) TraditionalCleared Feb 9, 1994112-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

Wallach Surgical Devices, Inc. · GEH Unit, Cryosurgical, Accessories

Cleared on Feb 9, 1994 after a 112-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 18 later devices descend from it.

Decided: Feb 9, 1994
Review: 112 days
Class: Class II
Product code: GEH
Recalls: None
Predicates: 0

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

This deviceK935010 Wallach Ultra FreezeWallach Surgical Devices, Inc. · 1994
Descendant · cites it directly · 16 of its ownK040809 Crymed Cryo-AblatorCrymed Technologies, Inc. · 2004
Descendant · cites it directly · 15 of its ownK060555 Spraygenix Cryo Ablation SystemCrymed Technologies, Inc. · 2006
Descendant · 2 generations on · 13 of its ownK070893 Cryospray Ablation System, Model CU 8407020500CSA Medical, Inc. · 2007
Descendant · 2 generations on · 11 of its ownK101825 Cryoballoon Ablation SystemC2 Therapeutics · 2010
Descendant · 3 generations on · 10 of its ownK131523 Cryoballoon Focal Ablation SystemC2 Therapeutics · 2013 · Recalled

Showing 5 of 18 descendants. See all descendants

Descendants cleared per year

2004high 3 (2016) · low 0 (2005)2026

Most influential descendants

Showing 5 of 18 · See all

K040809Crymed Cryo-AblatorCrymed Technologies, Inc. · 2004 · cites it directly16descendants
K060555Spraygenix Cryo Ablation SystemCrymed Technologies, Inc. · 2006 · cites it directly15descendants
K070893Cryospray Ablation System, Model CU 8407020500CSA Medical, Inc. · 2007 · 2 generations on13descendants
K101825Cryoballoon Ablation SystemC2 Therapeutics · 2010 · 2 generations on11descendants
K131523Cryoballoon Focal Ablation SystemC2 Therapeutics · 2013 · 3 generations on10descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K935010	Wallach Ultra Freeze	Wallach Surgical Devices, Inc.	1994	—
+1	K040809	Crymed Cryo-Ablator	Crymed Technologies, Inc.	2004	—
+1	K060555	Spraygenix Cryo Ablation System	Crymed Technologies, Inc.	2006	—
+2	K070893	Cryospray Ablation System, Model CU 8407020500	CSA Medical, Inc.	2007	—
+2	K101825	Cryoballoon Ablation System	C2 Therapeutics	2010	—
+3	K131523	Cryoballoon Focal Ablation System	C2 Therapeutics	2013	2

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0
2006	1	0
2007	2	0
2010	1	0
2012	1	0
2013	1	0
2015	1	0
2016	3	0
2017	1	0
2018	1	0
2019	1	0
2020	2	0
2021	1	0
2024	1	0

FIG. 1 — Lineage of K935010, 1994–2024Source: 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.

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

Get a 510(k) 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? (18)

See all 18

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

Number	Device	Applicant	Decided	Descendants
K040809	Crymed Cryo-Ablator	Crymed Technologies, Inc.	2004	16
K060555	Spraygenix Cryo Ablation System	Crymed Technologies, Inc.	2006	15
K193619	Cry-Ac®, Cry-Ac-3®, Cry-Baby	Brymill Cryogenic Systems	2020	0

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, K040809 (Crymed Technologies, Inc., 2004) has gone furthest, with 16 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/K935010 · printed Nov 4, 2026

Cite this page

510(k) Report. “K935010: Wallach Ultra Freeze.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K935010

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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