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# Capillary Bio Wearable Infusion Set Cleared
- URL: https://www.fdaweb.com/capillary-bio-wearable-infusion-set-cleared/
- Published: 2025-05-13T12:00:00.000Z
- Updated: 2026-09-14T15:11:41.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5159172

FDA has cleared a Capillary Biomedical 510(k) for its SteadiSet, a wearable infusion set that delivers insulin from a pump to the body for up to three days of use in Type 1 diabetes patients. The device features an integrated inserter with a hidden needle designed for one-handed insertion, according to the company. A separate 510(k) submission is planned to extend the indicated use time of SteadiSet for up to seven days.