FDA Product Code PBP: Rectal Insert
Acts As A Barrier To The Passage Of Fecal Matter Through The Rectum.
Leading manufacturers include Renew Medical, Inc. and Minnesota Medical Technologies.
2
Total
2
Cleared
187d
Avg days
2012
Since
Growing category -
1 submissions in the last 2 years
vs 0 in the prior period
Review times increasing: avg
265d
recently vs 109d historically
FDA 510(k) Cleared Rectal Insert Devices (Product Code PBP)
2 devices
Cleared
Jul 22, 2025
Minnesota Medical Technologies Fecal Incontinence Insert (My Miracle)
Minnesota Medical Technologies
Gastroenterology & Urology
265d
Cleared
Oct 26, 2012
RENEW INSERT
Renew Medical, Inc.
Gastroenterology & Urology
109d
About Product Code PBP - Regulatory Context
510(k) Submission Activity
2 total 510(k) submissions under product code PBP since 2012, with 2 receiving FDA clearance (average review time: 187 days).
Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
FDA 510(k) Review Time - PBP Product Code
Recent submissions under PBP have taken an average of 265 days to reach a decision - up from 109 days historically. Manufacturers should account for longer review timelines in current project planning.
PBP devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →