21 CFR 874.5220 — Pump, Nebulizer, Manual
Ear, Nose, Throat (EN) · Part 874 Subpart F—Therapeutic Devices · § 874.5220
Identification
An ear, nose, and throat drug administration device is one of a group of ear, nose, and throat devices intended specifically to administer medicinal substances to treat ear, nose, and throat disorders. These instruments include the powder blower, dropper, ear wick, manual nebulizer pump, and nasal inhaler.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| EPN | Pump, Nebulizer, Manual | 1 | 2 | |
| JPW | Pump, Nebulizer, Electrically Powered | 1 | 1 | |
| KCJ | Applicator, Ent | 1 | 4 | |
| KCL | Blower, Powder, Ent | 1 | 0 | |
| KCM | Dropper, Ent | 1 | 1 | |
| KCN | Ear Wick | 1 | 4 | |
| KCO | Nasal Spray, Ent Delivery | 1 | 1 | |
| KCP | Syringe, Ent | 1 | 4 | |
| LRD | Applicator, Ent Drug | 1 | 6 |
