Data / Medical devices / Dropper, Ent
Dropper, Ent (KCM): 14 FDA-registered makers in 5 countries
14 establishments in 5 countries are registered with the FDA to make Dropper, Ent (product code KCM, Class 1, 21 CFR 874.5220). 0 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 1 510(k) clearance under this code, the latest on August 2, 1984, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- KCM
- Device class
- 1
- Regulation
- 874.5220
- Medical specialty
- Ear, Nose, Throat
Makers by country
| Country | Makers |
|---|---|
| China | 5 |
| United States | 4 |
| Pakistan | 2 |
| United Kingdom | 2 |
| India | 1 |
Makers of Dropper, Ent
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Apothecary Products, LLC. | Burnsville, MN, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Crown Surgical Corp. | Sialkot Punjab, Pakistan | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dongguan City Yuankang Silicon Metal Products Co.,ltd | Dongguan Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Falcon Surgical Co. (Pvt.) Ltd. | Sialkot Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guangzhou Baoli Hardware & Electronic Co.,ltd. | Guangzhou Guangdong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gesco Healthcare Private Limited | CHENNAI, Tamil Nadu, India | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lianyungang Brilliant Industrial Co., Ltd. | LIANYUNGANG Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ningbo Albert Novosino Co., Ltd. | Yuyao Zhejiang, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Owen Mumford, Ltd. | Woodstock, Oxfordshire, United Kingdom | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Oogie Solutions LLC | Potomac, MD, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Owen Mumford Limited | Chipping Norton Oxfordshire, United Kingdom | Complaint file establishment, Contract manufacturer, Foreign private label distributor, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pro-Optics LLC | Palatine, IL, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| SHENZhEN KEAN SILICONE PRODUCT CO., LTD. | Shenzhen Guangdong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| SRC Medical, Inc. | Hanover, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated August 2, 1984. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.