FDA product code LDD: Dc-Defibrillator, Low-Energy, (Including Paddles)
LDD is the FDA product code for dc-defibrillator, low-energy, (including paddles). It is a Class II device, regulated under 21 CFR 870.5300 and reviewed by the Cardiovascular panel. FDA has cleared 166 510(k) submissions under LDD, from 70 different applicants. The average 510(k) review took 120 days (median 94). FDA has posted 31 recalls for LDD devices, 5 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Dc-Defibrillator, Low-Energy, (Including Paddles) |
| Device class | Class II |
| Regulation | 21 CFR 870.5300 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
| Life-sustaining or supporting | Yes |
510(k) clearances per year for LDD
| Year | Clearances | Avg. review days |
|---|---|---|
| 2019 | 1 | 264 |
| 2020 | 1 | 115 |
| 2021 | 1 | 70 |
Compare with all 510(k) review times · Search every LDD clearance
Top LDD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Physio-Control Corp. | 15 | 1994-03-16 |
| Cardiotronics, Inc. | 14 | 1992-09-18 |
| Nihon Kohden America, Inc. | 8 | 1997-10-21 |
| Zoll Medical Corp | 7 | 2004-10-26 |
| Marquette Electronics, Inc. | 7 | 1996-11-19 |
65 more applicants have LDD clearances. See the full list in Caduvo.
Most recent LDD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K203231 | Philips North America, LLC | Switched Internal Paddles | 2021-01-11 | 70 |
| K200849 | Remote Diagnostic Technologies, Ltd. A Philips Company | Tempus LS - Manual | 2020-07-24 | 115 |
| K182503 | Physio-Control, Inc. | Sterilizable Internal Defibrillation Paddles for use with LIFEPAK defibrillators/monitors | 2019-06-03 | 264 |
| K150349 | Full Power Aed | Rapid Hair Removal Pads | 2015-07-14 | 153 |
| K140502 | ZOLL Medical Corporation | ZOLL E SERIES ALS | 2014-11-06 | 252 |
Recalls for LDD devices
31 product recalls in 23 recall events; 5 initiated in the last five years and 4 still open. Most recent: 2024-10-28.
| Year | Recalls |
|---|---|
| 2020 | 1 |
| 2022 | 1 |
| 2023 | 1 |
| 2024 | 3 |
Frequently asked questions
What is FDA product code LDD?
LDD is the FDA product code for dc-defibrillator, low-energy, (including paddles). It is a Class II device, regulated under 21 CFR 870.5300 and reviewed by the Cardiovascular panel.
What device class is LDD?
Class II, regulation 21 CFR 870.5300. Typical premarket route: 510(k).
How long does a 510(k) take for product code LDD?
Across 166 cleared submissions the average was 120 days from receipt to decision (median 94).
Which companies have the most LDD clearances?
Physio-Control Corp. (15); Cardiotronics, Inc. (14); Nihon Kohden America, Inc. (8); Zoll Medical Corp (7); Marquette Electronics, Inc. (7).
Have LDD devices been recalled?
Yes: 31 product recalls across 23 recall events; the most recent began 2024-10-28.
Next steps
- Run an FDA pathway report with predicate devices for product code LDD
- Run a recall and safety report across every LDD manufacturer
- Watch product code LDD 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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