# Bowel Management Systems, LLC

- Location (FDA's records): Fernandina Beach, FL
- FDA decisions: 2 (2002–2002): 2 510(k) clearances
- Product codes: KNT (2)
- Predicates its devices cite: 5 (1 its own); citations of its devices by later devices: 8 (1 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Hdc Corp.: 2 (https://510kreport.com/company/hdc)
- Leon'S Fecal Sanitary Tub Mfg.: 2 (https://510kreport.com/company/leon-s-fecal-sanitary-tub-mfg)

## Firms that cite its devices most
- Hollister, Inc.: 2 (https://510kreport.com/company/hollister)
- Convatec, A Bristol-Myers Squibb Co.: 1 (https://510kreport.com/company/convatec-a-bristol-myers-squibb)
- Coloplast A/S: 1 (https://510kreport.com/company/coloplast-a-s)
- C.R. Bard, Inc.: 1 (https://510kreport.com/company/cr-bard)
- Convatec Limited: 1 (https://510kreport.com/company/convatec)
- Hospi Corporation: 1 (https://510kreport.com/company/hospi)

## Its most-cited devices
- K023344: Indwelling Fecal Management System-Non-Sterile (2002), cited by 4
- K012113: Indwelling Fecal Management System (2002), cited by 4

## Recent decisions
- K023344: Indwelling Fecal Management System-Non-Sterile (Nov 6, 2002)
- K012113: Indwelling Fecal Management System (May 3, 2002)

Source page: https://510kreport.com/company/bowel-management-systems