Product code KCM
- Device name
- Dropper, Ent
- Medical specialty
- Ear, Nose, Throat
- Device class
- 1
- Regulation number
- 874.5220
- Review panel
- EN
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- Y
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K840907 | POST-AID | E.W. Link, Inc. | 1984-08-02 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00384706150017 | AutoSqueeze | OWEN MUMFORD USA INCORPORATED | 2023-06-20 |
| 00384706050010 | AutoDrop | OWEN MUMFORD USA INCORPORATED | 2023-06-20 |
| 00384706100012 | AutoSqueeze | OWEN MUMFORD USA INCORPORATED | 2023-06-07 |
| 00384706000022 | AutoDrop | OWEN MUMFORD USA INCORPORATED | 2023-06-07 |
| 00384706000015 | AutoDrop | OWEN MUMFORD USA INCORPORATED | 2023-06-07 |
| 00076855100059 | Apex | Drive Devilbiss Healthcare | 2023-03-10 |
| 30635515992642 | Apex | COMPASS HEALTH BRANDS CORP. | 2023-03-10 |
| 30076855100050 | Apex | COMPASS HEALTH BRANDS CORP. | 2023-03-10 |
| 00635515992641 | Apex | Drive Devilbiss Healthcare | 2023-03-10 |
| 30041520876479 | Apex | COMPASS HEALTH BRANDS CORP. | 2023-02-15 |
| 00635515992665 | Apex | Drive Devilbiss Healthcare | 2023-02-15 |
| 30076855700076 | Apex | COMPASS HEALTH BRANDS CORP. | 2023-01-08 |
| 00076855005088 | Apex | Drive Devilbiss Healthcare | 2023-01-08 |
| 30076855700052 | Apex | COMPASS HEALTH BRANDS CORP. | 2023-01-08 |
| 30076855005089 | Apex | COMPASS HEALTH BRANDS CORP. | 2023-01-08 |
| 00076855700075 | Apex | Drive Devilbiss Healthcare | 2023-01-08 |
| 00076855700051 | Apex | Drive Devilbiss Healthcare | 2023-01-08 |
| 00076855601051 | Apex | Drive Devilbiss Healthcare | 2022-12-12 |
| 00076855605059 | Apex | Drive Devilbiss Healthcare | 2022-12-12 |
| 30076855605050 | Apex | COMPASS HEALTH BRANDS CORP. | 2022-12-12 |
| 30076855601052 | Apex | COMPASS HEALTH BRANDS CORP. | 2022-12-12 |
| 00385640005524 | INSTRUSAFE | Summit Medical, Inc. | 2021-05-18 |
| 00385640005838 | INSTRUSAFE | Summit Medical, Inc. | 2021-05-18 |
| 00385640005883 | INSTRUSAFE | Summit Medical, Inc. | 2021-05-18 |
| 00385640005937 | INSTRUSAFE | Summit Medical, Inc. | 2021-05-18 |
| 00385640005982 | INSTRUSAFE | Summit Medical, Inc. | 2021-05-18 |
| 00385640006033 | INSTRUSAFE | Summit Medical, Inc. | 2021-05-18 |
| 00385640013437 | INSTRUSAFE | Summit Medical, Inc. | 2021-05-18 |
| 00385640005531 | INSTRUSAFE | Summit Medical, Inc. | 2017-11-10 |