FDA product code DRC: Trocar
DRC is the FDA product code for trocar. It is a Class II device, regulated under 21 CFR 870.1390 and reviewed by the Cardiovascular panel. FDA has cleared 51 510(k) submissions under DRC, 4 in the last five years, from 33 different applicants. The average 510(k) review took 123 days (median 108); 104 days on average over the last three years. FDA has posted 11 recalls for DRC devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Trocar |
| Device class | Class II |
| Regulation | 21 CFR 870.1390 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) exempt |
510(k) clearances per year for DRC
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 2 | 159 |
| 2018 | 2 | 146 |
| 2021 | 1 | 29 |
| 2022 | 2 | 155 |
| 2024 | 2 | 104 |
Compare with all 510(k) review times · Search every DRC clearance
Top DRC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Pressure Products Medical Device Manufacturing, LLC | 7 | 2024-05-17 |
| Medical Device Technologies, Inc. | 3 | 1998-04-06 |
| North American Instrument Corp. | 3 | 1987-05-07 |
| Oscor, Inc. | 2 | 2014-01-08 |
| St Jude Medical | 2 | 2013-02-07 |
28 more applicants have DRC clearances. See the full list in Caduvo.
Most recent DRC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K240246 | Synaptic Medical Corporation | Accusafe Transseptal Guidewire (GTR31180, GTR31230) | 2024-07-26 | 178 |
| K241042 | Pressure Products Medical Device Manufacturing, LLC | SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198) | 2024-05-17 | 30 |
| K221707 | Pressure Products Medical Device Manufacturing, LLC | SafeSept® Transseptal Guidewire (SS-140) | 2022-09-14 | 93 |
| K212625 | Shanghai Microport EP Medtech Co., Ltd. | PathBuilder Transseptal Needle | 2022-03-23 | 217 |
| K210328 | Pressure Products Medical Device Manufacturing, LLC | SafeSept Blunt Needle | 2021-03-05 | 29 |
Recalls for DRC devices
11 product recalls in 10 recall events; 2 initiated in the last five years and 1 still open. Most recent: 2024-03-01.
| Year | Recalls |
|---|---|
| 2018 | 1 |
| 2019 | 1 |
| 2021 | 3 |
| 2024 | 1 |
Frequently asked questions
What is FDA product code DRC?
DRC is the FDA product code for trocar. It is a Class II device, regulated under 21 CFR 870.1390 and reviewed by the Cardiovascular panel.
What device class is DRC?
Class II, regulation 21 CFR 870.1390. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code DRC?
Across 51 cleared submissions the average was 123 days from receipt to decision (median 108).
Which companies have the most DRC clearances?
Pressure Products Medical Device Manufacturing, LLC (7); Medical Device Technologies, Inc. (3); North American Instrument Corp. (3); Oscor, Inc. (2); St Jude Medical (2).
Have DRC devices been recalled?
Yes: 11 product recalls across 10 recall events; the most recent began 2024-03-01.
Next steps
- Run an FDA pathway report with predicate devices for product code DRC
- Run a recall and safety report across every DRC manufacturer
- Watch product code DRC 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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