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# SafKan Impacted Earwax Device Cleared
- URL: https://www.fdaweb.com/safkan-impacted-earwax-device-cleared/
- Published: 2020-11-12T12:00:00.000Z
- Updated: 2026-09-14T16:36:12.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5148078

FDA has cleared a SafKan Health 510(k) for its OtoSet Ear Cleaning System for removing impacted earwax. The device is an alternative to the time-tested ear bladder syringe. The device features a combination “irrigation and microsuction technology built into an automated and wearable device.” The company says it is developing a consumer version of the OtoSet that can be used to prevent excessive earwax buildup at home.