FDA product code LDF: Electrode, Pacemaker, Temporary
LDF is the FDA product code for electrode, pacemaker, temporary. It is a Class II device, regulated under 21 CFR 870.3680 and reviewed by the Cardiovascular panel. FDA has cleared 130 510(k) submissions under LDF, 7 in the last five years, from 60 different applicants. The average 510(k) review took 133 days (median 88); 286 days on average over the last three years. FDA has posted 15 recalls for LDF devices, 4 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Electrode, Pacemaker, Temporary |
| Device class | Class II |
| Regulation | 21 CFR 870.3680 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
| Life-sustaining or supporting | Yes |
510(k) clearances per year for LDF
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 27 |
| 2018 | 1 | 219 |
| 2019 | 1 | 142 |
| 2024 | 1 | 270 |
| 2025 | 5 | 192 |
| 2026 | 1 | 395 |
Compare with all 510(k) review times · Search every LDF clearance
Top LDF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Medtronic Vascular | 21 | 2004-09-07 |
| C.R. Bard, Inc. | 8 | 2025-05-15 |
| Electro-Catheter Corp. | 7 | 1995-07-27 |
| ETHICON, Inc. | 5 | 2018-08-02 |
| Cordis Corp. | 5 | 1985-09-16 |
55 more applicants have LDF clearances. See the full list in Caduvo.
Most recent LDF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K252042 | Swift Sync, Inc. | Sync AV II Temporary Pacing Catheter | 2026-07-30 | 395 |
| K242863 | Bioptimal International Pte. , Ltd. | Bioptimal Bipolar Pacing Catheter | 2025-06-15 | 268 |
| K251186 | C.R. Bard, Inc. | Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer) | 2025-05-15 | 29 |
| K241334 | C.R. Bard, Inc. | Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 4Fr. (006221P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 5Fr. (006225P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 125 cm, 6Fr. (006241P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 125 cm, 7Fr. (006242P); NBIH Temporary Pacing Electrode Catheter, | 2025-01-31 | 266 |
| K241199 | Shenzhen Launch Electrical Co., Ltd. | Rotatable Connector (5944RL) | 2025-01-23 | 268 |
Recalls for LDF devices
15 product recalls in 11 recall events; 4 initiated in the last five years and 4 still open. Most recent: 2026-04-21.
| Year | Recalls |
|---|---|
| 2018 | 1 |
| 2019 | 1 |
| 2024 | 3 |
| 2026 | 1 |
Frequently asked questions
What is FDA product code LDF?
LDF is the FDA product code for electrode, pacemaker, temporary. It is a Class II device, regulated under 21 CFR 870.3680 and reviewed by the Cardiovascular panel.
What device class is LDF?
Class II, regulation 21 CFR 870.3680. Typical premarket route: 510(k).
How long does a 510(k) take for product code LDF?
Across 130 cleared submissions the average was 133 days from receipt to decision (median 88).
Which companies have the most LDF clearances?
Medtronic Vascular (21); C.R. Bard, Inc. (8); Electro-Catheter Corp. (7); ETHICON, Inc. (5); Cordis Corp. (5).
Have LDF devices been recalled?
Yes: 15 product recalls across 11 recall events; the most recent began 2026-04-21.
Next steps
- Run an FDA pathway report with predicate devices for product code LDF
- Run a recall and safety report across every LDF manufacturer
- Watch product code LDF 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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