510(k) · Cleared
ClearedHydrozid Precise
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bibawo Medical A/S · GEH Unit, Cryosurgical, Accessories
Cleared on May 30, 2023 as substantially equivalent to K201740 (Medilink A/S, 2021) after a 334-day review. Its family tree reaches back 4 generations to 1988.
- Decided
- May 30, 2023
- Review
- 334 days
- Class
- Class II
- Product code
- GEH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K881349 (1988). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK881349 Verruca-Freeze (TM) Cryotherapy Delivery SystemCryosurg, Inc. · 1988
- 3 generations backK130995 Nuance Cryo-Freeze Spray or Cryo-in-a-Can or Vandolay Freeze SprayNuance Medical, LLC · 2013
- 2 generations backK161296 Cool RenewalCool Renewal, LLC · 2016
- 1 generation backK201740 HydrozidMedilink A/S · 2021
- This deviceK221897 Hydrozid PreciseBibawo Medical A/S · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K881349 | Verruca-Freeze (TM) Cryotherapy Delivery System | Cryosurg, Inc. | 1988 | — |
| −3 | K130995 | Nuance Cryo-Freeze Spray or Cryo-in-a-Can or Vandolay Freeze Spray | Nuance Medical, LLC | 2013 | — |
| −2 | K161296 | Cool Renewal | Cool Renewal, LLC | 2016 | — |
| −1 | K201740 | Hydrozid | Medilink A/S | 2021 | — |
| 0 (this device) | K221897 | Hydrozid Precise | Bibawo Medical A/S | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1999 | 1 | 0 |
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.
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? (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 | Decided |
|---|---|---|---|
| * | K201740 | HydrozidSummary page 4…Classification Regulation: 21 CFR 878.4350 Device: Class II Device Product Code: GEH Device Panel: General & Plastic Surgery Predicate Device: Hydrozid® (K201740) manufactured by BIBAWO Medical A/S is the predicate device. 5.1. Description of the Device Hydrozid Precise™ is… | 2021 |
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?
- The line of descent spans 35 years and passes through 5 companies; a new generation was cleared every 5.0 years on median.
- None of the 6 ancestors has a recall.
How does its category compare?
All GEH devicesGEH Unit, Cryosurgical, Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
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?
Hydrozid Precise contains 1,1,1,2-tetrafluoroethane (also known as R134A, HFC-134a, HFA-134a or fluorocarbon 134a) and is to be used for the treatment of verruca (warts), including plantar warts, seborrheic keratosis, actinic keratosis, acrochordon (skin tags), molluscum contagiosum, age spots (lentigo), dermatofibroma, small keloids, granuloma annulare, porokeratosis plantaris, angiomas, keratoacanthoma, chondrodermatitis, epithelial nevus, leukoplakia, granuloma pyogenicum, and pyogenic granuloma.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221897 · printed Nov 4, 2026
Cite this page
510(k) Report. “K221897: Hydrozid Precise.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K221897
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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