# Ototech, Ltd.

- Location (FDA's records): Minneapolis, MN
- FDA decisions: 5 (1991–2001): 5 510(k) clearances
- Names in FDA's records: Ototech, Ltd. (4); Ototech, Inc. (1)
- Product codes: ESD (4), NEA (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 2 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Walter Lorenz Surgical, Inc.: 1 (https://510kreport.com/company/walter-lorenz-surgical)
- Envoy Medical Corporation: 1 (https://510kreport.com/company/envoy-medical)

## Its most-cited devices
- K011338: Oto-Cem (2001), cited by 2

## Recent decisions
- K011338: Oto-Cem (Sep 13, 2001)
- K910313: Abra Ipc Model Input Compres Agccust Ite Hear Aid (Mar 18, 1991)
- K910314: C Abra Model Linear, Low DR. Custom Canal Hear Aid (Mar 18, 1991)
- K910312: C Abra Model Linear, Low Drain Cust Canal Hear Aid (Mar 18, 1991)
- K910311: Abra Model Line Low Drain Cust in-the-Ear Hear Aid (Mar 18, 1991)

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