FDA product code LRD: Applicator, Ent Drug
LRD is the FDA product code for applicator, ent drug. It is a Class I device, regulated under 21 CFR 874.5220 and reviewed by the Ear, Nose and Throat panel. FDA has cleared 6 510(k) submissions under LRD, from 6 different applicants. The average 510(k) review took 178 days (median 122). FDA has posted 1 recall for LRD devices.
Classification
| Field | Value |
|---|---|
| Device name | Applicator, Ent Drug |
| Device class | Class I |
| Regulation | 21 CFR 874.5220 |
| Review panel | EN — Ear, Nose and Throat |
| Medical specialty | Ear, Nose, Throat |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every LRD clearance
Top LRD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Envis, Inc. | 1 | 1999-03-19 |
| Amsco Sterile Recoveries, Inc. | 1 | 1994-09-09 |
| The Merlin Corp. | 1 | 1994-08-12 |
| Denver Splint Co. | 1 | 1994-05-23 |
| Customed, Inc. | 1 | 1993-04-26 |
1 more applicants have LRD clearances. See the full list in Caduvo.
Most recent LRD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K984345 | Envis, Inc. | AROMAPATCH | 1999-03-19 | 105 |
| K932522 | Amsco Sterile Recoveries, Inc. | AMSCO STERILE RECOVERIES SURGICAL PACKS | 1994-09-09 | 472 |
| K942789 | The Merlin Corp. | MISTASSIST | 1994-08-12 | 59 |
| K940133 | Denver Splint Co. | THE EXPANDACELL EAR PACK | 1994-05-23 | 140 |
| K925022 | Customed, Inc. | SURGICAL TRAY (STERILE) | 1993-04-26 | 214 |
Recalls for LRD devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2015-09-03.
Frequently asked questions
What is FDA product code LRD?
LRD is the FDA product code for applicator, ent drug. It is a Class I device, regulated under 21 CFR 874.5220 and reviewed by the Ear, Nose and Throat panel.
What device class is LRD?
Class I, regulation 21 CFR 874.5220. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code LRD?
Across 6 cleared submissions the average was 178 days from receipt to decision (median 122).
Which companies have the most LRD clearances?
Envis, Inc. (1); Amsco Sterile Recoveries, Inc. (1); The Merlin Corp. (1); Denver Splint Co. (1); Customed, Inc. (1).
Have LRD devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2015-09-03.
Next steps
- Run an FDA pathway report with predicate devices for product code LRD
- Run a recall and safety report across every LRD manufacturer
- Watch product code LRD 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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