510(k) · Cleared

Cleared

Cryopen and Accessories

K012214510(k) TraditionalCleared Apr 26, 2002284-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

Cimex Biotech, LLC · GEH Unit, Cryosurgical, Accessories

Cleared on Apr 26, 2002 as substantially equivalent to K803311 (Wallach Surgical Devices, Inc., 1981) after a 284-day review. Its family tree reaches back 1 generation to 1981.

Decided: Apr 26, 2002
Review: 284 days
Class: Class II
Product code: GEH
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K803311 (1981). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK803311 LL100 Cryosurgical SystemWallach Surgical Devices, Inc. · 1981 · Recalled
This deviceK012214 Cryopen and AccessoriesCimex Biotech, LLC · 2002

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K803311	LL100 Cryosurgical System	Wallach Surgical Devices, Inc.	1981	3
0 (this device)	K012214	Cryopen and Accessories	Cimex Biotech, LLC	2002	—

FIG. 1 — Lineage of K012214, 1981–2002Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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.

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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	Applicant	Decided	Recalls
*	K803311	LL100 Cryosurgical System Summary page 2 …CP-006001-01 E. Substantial Equivalence The CryoPen System is Substantially Equivalent to the Wallach LL100 Predicate Device, approved on February 04, 1981, (reference K803311). The CryoPen and the Wallach LL100 destroy tissue using cryogenic temperatures. The contacting metal incorporated in the cryotip…	Wallach Surgical Devices, Inc.	1981	3
†	K981299	Silverlon Contact Wound Dressing	Argentum International, LLC	1998	—

Also cleared against K803311: 1 other device →

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 a recall.
1 other device also cites its predicate K803311.

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	—

What is it indicated for?

Cryosurgical unit used for ablative type surgical technique

Multiple organ systems, wide range of disease, viral, premalignant and malignant tissue.

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/K012214 · printed Nov 5, 2026

Cite this page

510(k) Report. “K012214: Cryopen and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K012214

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026