510(k) · Cleared
ClearedHistofreezer Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
OraSure Technologies, Inc. · GEH Unit, Cryosurgical, Accessories
Cleared on Jun 14, 1999 after a 90-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 6 later devices descend from it.
- Decided
- Jun 14, 1999
- Review
- 90 days
- Class
- Class II
- Product code
- GEH
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 3 citing it directly.
- This deviceK990877 Histofreezer DeviceOraSure Technologies, Inc. · 1999
- Descendant · cites it directly · 3 of its ownK161337 CryoDose H or SimilarNuance Medical, LLC · 2016
- Descendant · 2 generations on · 2 of its ownK233347 Verruca-Freeze® HCryosurgery, Inc. · 2023
- Descendant · 3 generations on · 1 of its ownK243454 Verruca-Freeze HCryosurgery, Inc. · 2024
- Descendant · 4 generations on · 0 of its ownK252903 Verruca-Freeze H PlusCryosurgery, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK152203 Utermohlen Cryo ProfessionalKoninklijke (Royal) Utermohlen · 2015
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K161337CryoDose H or SimilarNuance Medical, LLC · 2016 · cites it directly3descendants
- K233347Verruca-Freeze® HCryosurgery, Inc. · 2023 · 2 generations on2descendants
- K243454Verruca-Freeze HCryosurgery, Inc. · 2024 · 3 generations on1descendant
- K252903Verruca-Freeze H PlusCryosurgery, Inc. · 2025 · 4 generations on0descendants
- K152203Utermohlen Cryo ProfessionalKoninklijke (Royal) Utermohlen · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K990877 | Histofreezer Device | OraSure Technologies, Inc. | 1999 | — |
| +1 | K161337 | CryoDose H or Similar | Nuance Medical, LLC | 2016 | — |
| +2 | K233347 | Verruca-Freeze® H | Cryosurgery, Inc. | 2023 | — |
| +3 | K243454 | Verruca-Freeze H | Cryosurgery, Inc. | 2024 | — |
| +4 | K252903 | Verruca-Freeze H Plus | Cryosurgery, Inc. | 2025 | — |
| +1 | K152203 | Utermohlen Cryo Professional | Koninklijke (Royal) Utermohlen | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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.
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’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (6)
3 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, K161337 (Nuance Medical, LLC, 2016) has gone furthest, with 3 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 | — |
What is it indicated for?
The Histofreezer® device is indicated for use in the treatment of the following:
Actinic Keratosis
Genital Warts
Lentigo
Molluscum Contagiosum
Seborrhoeic Keratosis
Skin Tags
Verruca Plantaris
Verruca Vulgaris
Verruca Plana
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K990877 · printed Nov 4, 2026
Cite this page
510(k) Report. “K990877: Histofreezer Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K990877
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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