# Rusch, Inc.

- Location (FDA's records): Jeffrey, NH
- FDA decisions: 26 (1993–2001): 26 510(k) clearances
- Product codes: BTR (10), EZL (2), FCM (2), KOB (2), KNT (2), CBP (1), FPD (1), JOH (1), BTS (1), BSR (1), NYT (1), BTM (1)
- Predicates its devices cite: 6 (0 its own); citations of its devices by later devices: 27 (0 its own)
- Recalls linked to its devices: 48 (38 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Laerdal Medical Corp.: 1 (https://510kreport.com/company/laerdal-medical)
- Sheridan Catheter Corp.: 1 (https://510kreport.com/company/sheridan-catheter)
- Portex, Inc.: 1 (https://510kreport.com/company/portex)
- Urotec Systems Corp.: 1 (https://510kreport.com/company/urotec-systems)
- Smiths Industries Medical Systems, Inc.: 1 (https://510kreport.com/company/smiths-industries-medical-systems)
- Engineered Medical Systems: 1 (https://510kreport.com/company/engineered-medical-systems)

## Firms that cite its devices most
- Rusch Intl.: 5 (https://510kreport.com/company/rusch-intl)
- Tiger Medical Products, Ltd.: 4 (https://510kreport.com/company/tiger-medical-products)
- Medsource International, LLC: 3 (https://510kreport.com/company/medsource-international)
- Davis Medical: 2 (https://510kreport.com/company/davis-medical)
- Sainath Intellectual Properties, LLC: 2 (https://510kreport.com/company/sainath-intellectual-properties)
- Mediplus, Ltd.: 1 (https://510kreport.com/company/mediplus)
- Uc-Care Medical Systems, Ltd.: 1 (https://510kreport.com/company/uc-care-medical-systems)
- Cure Medical, LLC: 1 (https://510kreport.com/company/cure-medical)

## Its most-cited devices
- K931163: Rusch Agt PVC Preform Oral Trach Tub/Cuf W/Mur Eye (1993), cited by 4
- K931166: Rusch Agt PVC Pref Oral Trach Tube, Uncuf W/Mur EY (1993), cited by 3
- K010420: Rusch MMG/O'neil Catheter (2001), cited by 3
- K980870: Rusch Silicone Foley Catheter (1998), cited by 2
- K963993: Rusch Simplastic Foley Catheterization Set (1996), cited by 2
- K970021: Rusch Suprapubic Tray (1997), cited by 2

## Recent decisions
- K010420: Rusch MMG/O'neil Catheter (May 9, 2001)
- K993528: Rusch Emergency Mask (May 31, 2000)
- K993194: Rusch Manual Resuscitator Bag (Mar 24, 2000)
- K980870: Rusch Silicone Foley Catheter (Jun 9, 1998)
- K974419: Rusch Simplastic Councill Tip Catheter (Jan 27, 1998)
- K963779: Rusch Enteral Feeding Tube (May 23, 1997)
- K970021: Rusch Suprapubic Tray (Feb 7, 1997)
- K963993: Rusch Simplastic Foley Catheterization Set (Dec 17, 1996)

Source page: https://510kreport.com/company/rusch