510(k) · Cleared

Recalled · 2007

Gebauer's Instant Ice

K021726510(k) TraditionalCleared Dec 12, 2002202-day reviewClass URecalls 2

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

Gebauer Co. · MLY Vapocoolant Device

Cleared on Dec 12, 2002 as substantially equivalent to K991514 (Gebauer Co., 1999) after a 202-day review. Its family tree reaches back 1 generation to 1999. 29 later devices descend from it. It has been recalled 2 times.

Decided: Dec 12, 2002
Review: 202 days
Class: Class U
Product code: MLY
Recalls: 2
Predicates: 1

Its longest line of descent runs back 1 generation to K991514 (1999). 29 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 1 generation backK991514 Gebauer's Chloride Fine NozzeGebauer Co. · 1999
This deviceK021726 Gebauer's Instant IceGebauer Co. · 2002
Descendant · cites it directly · 14 of its ownK030281 Cryotron 2 Cryotherapy DeviceCryonic Medical North America · 2003
Descendant · 2 generations on · 13 of its ownK170810 CryofosCryofos Medical GmbH · 2017
Descendant · cites it directly · 11 of its ownK031036 Gebauer's Skin Refrigerant (Mist Spray), Model P/N 0386-0010-07…Gebauer Co. · 2003 · Recalled
Descendant · 2 generations on · 9 of its ownK032671 Gebauer's Skin Refrigerant (Mist Stream), Gebauer's Skin Refrigerant…Gebauer Co. · 2004 · Recalled
Descendant · 3 generations on · 6 of its ownK182392 Frozen CB.M. Tech. Worldwide Co., Ltd. · 2018

Showing 5 of 29 descendants. See all descendants

Descendants cleared per year

2003high 5 (2020) · low 0 (2006)2026

Most influential descendants

Showing 5 of 29 · See all

K030281Cryotron 2 Cryotherapy DeviceCryonic Medical North America · 2003 · cites it directly14descendants
K170810CryofosCryofos Medical GmbH · 2017 · 2 generations on13descendants
K031036Gebauer's Skin Refrigerant (Mist Spray), Model P/N 0386-0010-07, Gebauer's Skin…Gebauer Co. · 2003 · cites it directly11descendants
K032671Gebauer's Skin Refrigerant (Mist Stream), Gebauer's Skin Refrigerant (Stream Spray)…Gebauer Co. · 2004 · 2 generations on9descendants
K182392Frozen CB.M. Tech. Worldwide Co., Ltd. · 2018 · 3 generations on6descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K991514	Gebauer's Chloride Fine Nozze	Gebauer Co.	1999	—
0 (this device)	K021726	Gebauer's Instant Ice	Gebauer Co.	2002	—
+1	K030281	Cryotron 2 Cryotherapy Device	Cryonic Medical North America	2003	—
+2	K170810	Cryofos	Cryofos Medical GmbH	2017	—
+1	K031036	Gebauer's Skin Refrigerant (Mist Spray), Model P/N 0386-0010-07, Gebauer's…	Gebauer Co.	2003	1
+2	K032671	Gebauer's Skin Refrigerant (Mist Stream), Gebauer's Skin Refrigerant (Stream…	Gebauer Co.	2004	3
+3	K182392	Frozen C	B.M. Tech. Worldwide Co., Ltd.	2018	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	2	0
2004	1	0
2005	1	0
2016	1	0
2017	3	0
2018	2	0
2019	1	0
2020	5	0
2021	2	0
2022	4	0
2023	1	0
2024	1	0
2025	2	0
2026	3	0

FIG. 1 — Lineage of K021726, 1999–2026Source: 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 MLY? 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 MLY device

#1 K260870 Gebauer's Pain Ease Topical Anesthetic Skin…score 13.4 · 6 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? (2)

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
*	K991514	Gebauer's Chloride Fine Nozze Summary page 1 …Spray), to be sold as a non prescription over the counter product, which we claim i s substantially equivalent,toGebauer’s Ethyl Chloride@(Fine and Medium Nodes) 510 (k) K991514 and Mueller@Coolant Cold Spray (21CFR 807.85 and Premarket Notification 51O(k), “device in commercial distribution before May 28,…	Gebauer Co.	1999	—
*	—	Mueller Coolant Cold Spray Named without a submission number			—

Also cleared against K991514: 2 other devices →

What descends from it? (29)

See all 29

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

Number	Device	Applicant	Decided	Descendants
K030281	Cryotron 2 Cryotherapy Device	Cryonic Medical North America	2003	14
K031036	Gebauer's Skin Refrigerant (Mist Spray), Model P/N 0386-0010-07, Gebauer's Skin…	Gebauer Co.	2003	11
K172203	CryoDose TA OTC, Mist Spray, CryoDose TA OTC, Stream Spray	Nuance Medical, LLC	2017	0
K033720	Ari Cold Spray	Ari	2005	0

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Apr 17, 2007	Not classified	Z-1059-2007	Other	Mold contamination
Apr 17, 2007	Not classified	Z-1060-2007	Other	Mold contamination

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K030281 (Cryonic Medical North America, 2003) has gone furthest, with 14 descendants of its own.
2 other devices also cite its predicate K991514.

How does its category compare?

All MLY devices

MLY Vapocoolant Device: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MLY

1in 2025

2007high 3 (2020) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MLY

93in 2020

2007high 93 (2020)2026

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

Recalls per year · MLY

1in 2008

2007high 6 (2007) · low 0 (2009)2026

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

Adverse event reports per year · MLY

4in 2025

2007high 4 (2025) · low 0 (2007)2025

MAUDE reports naming product code MLY, 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	0	—	6	0
2008	0	—	1	1
2009	0	—	0	0
2010	1	—	0	0
2011	0	—	0	1
2012	0	—	0	1
2013	0	—	0	0
2014	0	—	0	2
2015	0	—	0	3
2016	1	—	0	1
2017	2	—	0	0
2018	1	—	0	2
2019	1	—	0	0
2020	3	93	0	0
2021	0	—	0	0
2022	1	—	0	2
2023	0	—	0	0
2024	1	—	0	2
2025	1	—	0	4
2026	2	—	0	—

What is it indicated for?

Gebauer’s Instant Ice™ (Mist Spray): Use like ice for the temporary relief and reduction of minor pain and swelling from sprains, strains, bruising, contusions or minor sports injuries.

Gebauer’s Instant Ice™ (Stream Spray): Use like ice for the temporary relief and reduction of minor pain and swelling from sprains, strains, bruising, contusions or minor sports injuries and muscle spasms.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K021726 · printed Nov 5, 2026

Cite this page

510(k) Report. “K021726: Gebauer's Instant Ice.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K021726

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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