FDA product code DTE: Pulse-Generator, Pacemaker, External
DTE is the FDA product code for pulse-generator, pacemaker, external. It is a Class II device, regulated under 21 CFR 870.3600 and reviewed by the Cardiovascular panel. FDA has cleared 65 510(k) submissions under DTE, 2 in the last five years, from 22 different applicants. The average 510(k) review took 111 days (median 72); 164 days on average over the last three years. 1 PMA application cites this product code. FDA has posted 5 recalls for DTE devices.
Classification
| Field | Value |
|---|---|
| Device name | Pulse-Generator, Pacemaker, External |
| Device class | Class II |
| Regulation | 21 CFR 870.3600 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
510(k) clearances per year for DTE
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 2 | 22 |
| 2019 | 2 | 86 |
| 2020 | 1 | 26 |
| 2024 | 1 | 124 |
| 2025 | 1 | 204 |
Compare with all 510(k) review times · Search every DTE clearance
Top DTE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Seamed Corp. | 13 | 1992-08-14 |
| Pace Medical | 9 | 2001-09-12 |
| Medtronic, Inc. | 8 | 2020-05-13 |
| Medtronic Vascular | 5 | 1997-07-14 |
| Osypka Medical, Inc. | 4 | 2013-04-09 |
17 more applicants have DTE clearances. See the full list in Caduvo.
Most recent DTE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K241781 | Solo Pace, Inc. | Solo Pace Control | 2025-01-10 | 204 |
| K232721 | Shenzhen Lifetech Cardio Medical Electronics Co., Ltd. | Lifetech Cardio Temporary Pacemaker | 2024-01-07 | 124 |
| K201011 | Medtronic, Inc. | Medtronic Model 5392 External Pulse Generator (EPG) | 2020-05-13 | 26 |
| K190825 | Medtronic, Inc. | Medtronic Model 5392 External Pulse Generator (EPG) | 2019-04-30 | 29 |
| K182839 | Shenzhen Lifetech Cardio Medical Electronics Co., Ltd. | Lifetech Cardio Model 8301 Temporary Pacemaker | 2019-02-28 | 142 |
Recalls for DTE devices
5 product recalls in 4 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2019-05-28.
| Year | Recalls |
|---|---|
| 2018 | 1 |
| 2019 | 1 |
HCPCS codes with matching descriptors
Text match between the FDA device name and CMS descriptors, not an official crosswalk:
- C8009 — Removal of hypoglossal nerve neurostimulator array and pulse generator
Frequently asked questions
What is FDA product code DTE?
DTE is the FDA product code for pulse-generator, pacemaker, external. It is a Class II device, regulated under 21 CFR 870.3600 and reviewed by the Cardiovascular panel.
What device class is DTE?
Class II, regulation 21 CFR 870.3600. Typical premarket route: 510(k).
How long does a 510(k) take for product code DTE?
Across 65 cleared submissions the average was 111 days from receipt to decision (median 72).
Which companies have the most DTE clearances?
Seamed Corp. (13); Pace Medical (9); Medtronic, Inc. (8); Medtronic Vascular (5); Osypka Medical, Inc. (4).
Have DTE devices been recalled?
Yes: 5 product recalls across 4 recall events; the most recent began 2019-05-28.
Next steps
- Run an FDA pathway report with predicate devices for product code DTE
- Run a recall and safety report across every DTE manufacturer
- Watch product code DTE 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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