FDA product code DRE: Dilator, Vessel, For Percutaneous Catheterization
DRE is the FDA product code for dilator, vessel, for percutaneous catheterization. It is a Class II device, regulated under 21 CFR 870.1310 and reviewed by the Cardiovascular panel. FDA has cleared 105 510(k) submissions under DRE, 10 in the last five years, from 68 different applicants. The average 510(k) review took 103 days (median 77); 67 days on average over the last three years. FDA has posted 40 recalls for DRE devices, 18 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Dilator, Vessel, For Percutaneous Catheterization |
| Device class | Class II |
| Regulation | 21 CFR 870.1310 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for DRE
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 4 | 138 |
| 2018 | 2 | 30 |
| 2019 | 3 | 115 |
| 2020 | 3 | 106 |
| 2021 | 1 | 26 |
| 2022 | 3 | 215 |
| 2023 | 2 | 30 |
| 2024 | 1 | 28 |
| 2025 | 3 | 77 |
| 2026 | 1 | 97 |
Compare with all 510(k) review times · Search every DRE clearance
Top DRE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Merit Medical Systems, Inc. | 10 | 2026-07-27 |
| Spectranetics, Inc. | 6 | 2022-12-15 |
| Baylis Medical Company, Inc. | 5 | 2025-05-29 |
| Cook Vascular, Inc. | 4 | 2014-11-12 |
| Cook Incorporated | 3 | 2021-04-06 |
63 more applicants have DRE clearances. See the full list in Caduvo.
Most recent DRE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K261310 | Merit Medical Systems, Inc. | FlexTract Deflectable-Rotational Dilator Sheath Set | 2026-07-27 | 97 |
| K253616 | Sorin Group Italia S.R.L. | ProtekDilate Vascular Access Kit | 2025-12-19 | 31 |
| K251325 | Baylis Medical Company, Inc. | VersaCross Connect Transseptal Dilator | 2025-05-29 | 30 |
| K242229 | Merit Medical Systems, Inc. | Micro Ace Gold Advanced Micro Access System | 2025-01-15 | 169 |
| K241720 | Baylis Medical Company, Inc. | VersaCross Connect Transseptal Dilator | 2024-07-12 | 28 |
Recalls for DRE devices
40 product recalls in 22 recall events; 18 initiated in the last five years and 18 still open. Most recent: 2026-06-01.
| Year | Recalls |
|---|---|
| 2018 | 1 |
| 2020 | 2 |
| 2021 | 2 |
| 2024 | 16 |
| 2025 | 1 |
| 2026 | 1 |
Frequently asked questions
What is FDA product code DRE?
DRE is the FDA product code for dilator, vessel, for percutaneous catheterization. It is a Class II device, regulated under 21 CFR 870.1310 and reviewed by the Cardiovascular panel.
What device class is DRE?
Class II, regulation 21 CFR 870.1310. Typical premarket route: 510(k).
How long does a 510(k) take for product code DRE?
Across 105 cleared submissions the average was 103 days from receipt to decision (median 77).
Which companies have the most DRE clearances?
Merit Medical Systems, Inc. (10); Spectranetics, Inc. (6); Baylis Medical Company, Inc. (5); Cook Vascular, Inc. (4); Cook Incorporated (3).
Have DRE devices been recalled?
Yes: 40 product recalls across 22 recall events; the most recent began 2026-06-01.
Next steps
- Run an FDA pathway report with predicate devices for product code DRE
- Run a recall and safety report across every DRE manufacturer
- Watch product code DRE 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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