FDA product code LDR: Controller, Infusion, Intravascular, Electronic
LDR is the FDA product code for controller, infusion, intravascular, electronic. It is a Class II device, regulated under 21 CFR 880.5725 and reviewed by the General Hospital panel. FDA has cleared 60 510(k) submissions under LDR, 2 in the last five years, from 38 different applicants. The average 510(k) review took 83 days (median 56); 120 days on average over the last three years. FDA has posted 5 recalls for LDR devices.
Classification
| Field | Value |
|---|---|
| Device name | Controller, Infusion, Intravascular, Electronic |
| Device class | Class II |
| Regulation | 21 CFR 880.5725 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) |
510(k) clearances per year for LDR
| Year | Clearances | Avg. review days |
|---|---|---|
| 2024 | 2 | 120 |
Compare with all 510(k) review times · Search every LDR clearance
Top LDR applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Y | 8 | 1989-09-27 |
| Travenol Laboratories, S.A. | 4 | 1986-02-12 |
| Abbott Laboratories | 3 | 1989-07-28 |
| Ivy Medical, Inc. | 3 | 1988-09-23 |
| Alexander Mfg. Co. | 2 | 1997-07-03 |
33 more applicants have LDR clearances. See the full list in Caduvo.
Most recent LDR clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K242693 | Deka Research and Development Corporation | DEKA Infusion System, DEKA Administration Set | 2024-10-07 | 28 |
| K232316 | Deka Research and Development | DEKA Infusion System, DEKA Administration Set | 2024-03-01 | 211 |
| K153760 | DEKA Research & Development | Volumetric Infusion Controller | 2016-10-03 | 278 |
| K963136 | Health Watch, Inc. | PACER MODEL 100 INFUSION CONTROLLER | 1997-10-10 | 423 |
| K971865 | Alexander Mfg. Co. | ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M12/500-3P | 1997-07-03 | 44 |
Recalls for LDR devices
5 product recalls in 4 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2017-06-19.
| Year | Recalls |
|---|---|
| 2017 | 1 |
Frequently asked questions
What is FDA product code LDR?
LDR is the FDA product code for controller, infusion, intravascular, electronic. It is a Class II device, regulated under 21 CFR 880.5725 and reviewed by the General Hospital panel.
What device class is LDR?
Class II, regulation 21 CFR 880.5725. Typical premarket route: 510(k).
How long does a 510(k) take for product code LDR?
Across 60 cleared submissions the average was 83 days from receipt to decision (median 56).
Which companies have the most LDR clearances?
Y (8); Travenol Laboratories, S.A. (4); Abbott Laboratories (3); Ivy Medical, Inc. (3); Alexander Mfg. Co. (2).
Have LDR devices been recalled?
Yes: 5 product recalls across 4 recall events; the most recent began 2017-06-19.
Next steps
- Run an FDA pathway report with predicate devices for product code LDR
- Run a recall and safety report across every LDR manufacturer
- Watch product code LDR 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.
All General Hospital product codes · FDA product code lookup · 510(k) database search · 510(k) review times