Dermal Cooling System
Model C2-001 · R2 Technologies, Inc. · DI 00850019947007
GEH — Unit, Cryosurgical, Accessories · Class II · 21 CFR 878.4350
MLY — Vapocoolant Device
UDILibrary device dossier · generated 2026-09-13 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.
Recall history (0)
No recalls linked in the loaded window.
Adverse-event reports — MAUDE (0)
Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 4 |
| 2019-02 | 0 | 1.25 |
| 2019-03 | 0 | 1.8 |
| 2019-04 | 0 | 2 |
| 2019-05 | 0 | 1.75 |
| 2019-06 | 0 | 1.5 |
| 2019-07 | 0 | 2.24 |
| 2019-08 | 0 | 1.89 |
| 2019-09 | 0 | 2.38 |
| 2019-10 | 0 | 2.46 |
| 2019-11 | 0 | 4.11 |
| 2019-12 | 0 | 3 |
| 2020-01 | 0 | 3 |
| 2020-02 | 0 | 5 |
| 2020-03 | 0 | 2.85 |
| 2020-04 | 0 | 4.25 |
| 2020-05 | 0 | 2.5 |
| 2020-06 | 0 | 2.75 |
| 2020-07 | 0 | 2.38 |
| 2020-08 | 0 | 2.82 |
| 2020-09 | 0 | 3.14 |
| 2020-10 | 0 | 1.25 |
| 2020-11 | 0 | 5 |
| 2020-12 | 0 | 1.22 |
| 2021-01 | 0 | 1.8 |
| 2021-02 | 0 | 5 |
| 2021-03 | 0 | 2.38 |
| 2021-04 | 0 | 1.9 |
| 2021-05 | 0 | 2.13 |
| 2021-06 | 0 | 2.25 |
| 2021-07 | 0 | 2 |
| 2021-08 | 0 | 2.8 |
| 2021-09 | 0 | 1.86 |
| 2021-10 | 0 | 1.33 |
| 2021-11 | 0 | 3.33 |
| 2021-12 | 0 | 2.67 |
| 2022-01 | 0 | 2.36 |
| 2022-02 | 0 | 1.25 |
| 2022-03 | 0 | 2 |
| 2022-04 | 0 | 1.77 |
| 2022-05 | 0 | 1.75 |
| 2022-06 | 0 | 2 |
| 2022-07 | 0 | 2.1 |
| 2022-08 | 0 | 3.57 |
| 2022-09 | 0 | 2.11 |
| 2022-10 | 0 | 2.1 |
| 2022-11 | 0 | 2.4 |
| 2022-12 | 0 | 1.43 |
| 2023-01 | 0 | 2.14 |
| 2023-02 | 0 | 1.3 |
| 2023-03 | 0 | 2.38 |
| 2023-04 | 0 | 1.7 |
| 2023-05 | 0 | 1.25 |
| 2023-06 | 0 | 1.29 |
| 2023-07 | 0 | 1.57 |
| 2023-08 | 0 | 3.2 |
| 2023-09 | 0 | 1.71 |
| 2023-10 | 0 | 1.45 |
| 2023-11 | 0 | 3 |
| 2023-12 | 0 | 1 |
| 2024-01 | 0 | 1.25 |
| 2024-02 | 0 | 1.44 |
| 2024-03 | 0 | 1.43 |
| 2024-04 | 0 | 1 |
| 2024-05 | 0 | 1 |
| 2024-06 | 0 | 1.4 |
| 2024-07 | 0 | 1.4 |
| 2024-08 | 0 | 1.33 |
| 2024-09 | 0 | 1.67 |
| 2024-10 | 0 | 2.17 |
| 2024-11 | 0 | 2 |
| 2024-12 | 0 | 2.5 |
| 2025-01 | 0 | 1.43 |
| 2025-02 | 0 | 1.33 |
| 2025-03 | 0 | 1.3 |
| 2025-04 | 0 | 1.86 |
| 2025-05 | 0 | 1.64 |
| 2025-07 | 0 | 2 |
| 2025-08 | 0 | 1.67 |
| 2025-09 | 0 | 2.2 |
| 2025-10 | 0 | 1.33 |
| 2025-11 | 0 | 1.89 |
| 2025-12 | 0 | 3.17 |
| 2026-01 | 0 | 2.83 |
| 2026-02 | 0 | 3 |
| 2026-03 | 0 | 2.08 |
| 2026-04 | 0 | 2.57 |
| 2026-05 | 0 | 3.17 |
| 2026-06 | 0 | 2.71 |
Regulatory clearances
- K201260 SESE 2020-09-24 (k number procode)
Predicate lineage
K201260 — cites (transitively): K171398 (d1), K182392 (d1), K161480 (d2), K170810 (d2), K110754 (d3), K152133 (d3), K030281 (d3), K111859 (d4), K113860 (d4), K121251 (d4), K123865 (d4), K140584 (d4), K143564 (d4), K963826 (d5), K060390 (d5) — cited as predicate by K203006
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — R2 Technologies, Inc.
Nothing in the loaded window.