FDA product code DRF: Catheter, Electrode Recording, Or Probe, Electrode Recording
DRF is the FDA product code for catheter, electrode recording, or probe, electrode recording. It is a Class II device, regulated under 21 CFR 870.1220 and reviewed by the Cardiovascular panel. FDA has cleared 185 510(k) submissions under DRF, 14 in the last five years, from 62 different applicants. The average 510(k) review took 169 days (median 114); 181 days on average over the last three years. 3 PMA applications cite this product code. FDA has posted 26 recalls for DRF devices.
Classification
| Field | Value |
|---|---|
| Device name | Catheter, Electrode Recording, Or Probe, Electrode Recording |
| Device class | Class II |
| Regulation | 21 CFR 870.1220 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
510(k) clearances per year for DRF
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 175 |
| 2019 | 9 | 144 |
| 2020 | 1 | 186 |
| 2021 | 5 | 178 |
| 2022 | 5 | 351 |
| 2023 | 4 | 44 |
| 2024 | 2 | 270 |
| 2025 | 2 | 145 |
| 2026 | 1 | 128 |
Compare with all 510(k) review times · Search every DRF clearance
Top DRF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Biosense Webster, Inc. | 19 | 2022-01-26 |
| St Jude Medical | 14 | 2016-12-13 |
| Ep Technologies, Inc. | 12 | 2005-02-03 |
| C.R. Bard, Inc. | 11 | 2009-06-05 |
| Irvine Biomedical, Inc. | 11 | 2008-08-19 |
57 more applicants have DRF clearances. See the full list in Caduvo.
Most recent DRF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K252794 | Imricor Medical Systems, Inc. | Vision-MR Diagnostic Catheter | 2026-01-08 | 128 |
| K250590 | Stereotaxis, Inc. | MAGiC Sweep EP Mapping Catheter | 2025-07-23 | 146 |
| K250310 | Boston Scientific Corporation | VIKING Fixed Curve Diagnostic Catheter | 2025-06-27 | 144 |
| K240366 | Boston Scientific Corporation | EPXT Unidirectional Steerable Diagnostic Catheter; Dynamic Tip Unidirectional Steerable Diagnostic Catheter; Dynamic XT Unidirectional Steerable Diagnostic Catheter | 2024-11-01 | 269 |
| K233900 | Synaptic Medical Corporation | Nordica PV Cryo Mapping Catheter | 2024-09-06 | 270 |
Recalls for DRF devices
26 product recalls in 19 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2020-08-24.
| Year | Recalls |
|---|---|
| 2018 | 1 |
| 2020 | 2 |
Frequently asked questions
What is FDA product code DRF?
DRF is the FDA product code for catheter, electrode recording, or probe, electrode recording. It is a Class II device, regulated under 21 CFR 870.1220 and reviewed by the Cardiovascular panel.
What device class is DRF?
Class II, regulation 21 CFR 870.1220. Typical premarket route: 510(k).
How long does a 510(k) take for product code DRF?
Across 185 cleared submissions the average was 169 days from receipt to decision (median 114).
Which companies have the most DRF clearances?
Biosense Webster, Inc. (19); St Jude Medical (14); Ep Technologies, Inc. (12); C.R. Bard, Inc. (11); Irvine Biomedical, Inc. (11).
Have DRF devices been recalled?
Yes: 26 product recalls across 19 recall events; the most recent began 2020-08-24.
Next steps
- Run an FDA pathway report with predicate devices for product code DRF
- Run a recall and safety report across every DRF manufacturer
- Watch product code DRF for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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