# OTU Medical, Inc.

- Location (FDA's records): San Jose, CA
- FDA decisions: 5 (2018–2023): 5 510(k) clearances
- Product codes: FAJ (2), FGB (2), EOQ (1)
- 510(k) review time since 2016: median 125 days, against 191 for FDA's reviews in the same codes and years (4 of 5 faster)
- Predicates its devices cite: 6 (2 its own); citations of its devices by later devices: 4 (2 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
- Ambu A/S: 2 (https://510kreport.com/company/ambu-a-s)
- Acmi Corporation: 1 (https://510kreport.com/company/acmi)
- Zhuhai Pusen Medical Technology Co., Ltd.: 1 (https://510kreport.com/company/zhuhai-pusen-medical-technology)

## Firms that cite its devices most
- Dyne Medical Group, Inc.: 1 (https://510kreport.com/company/dyne-medical-group)
- Shenzhen HugeMed Medical Technical Development Co., Ltd.: 1 (https://510kreport.com/company/shenzhen-hugemed-medical-technical-development)

## Its most-cited devices
- K181977: WiScope Digital Endoscope System (2018), cited by 2
- K210579: WiScope OM Endoscope System, WiScope Single-Use Digital Flexible Ureteroscope.Choledochoscope, WiScope Image System (2021), cited by 1
- K212202: WiScope Digital Cystoscope System, WiScope Single-Use Digital Flexible Cystoscope, WiScope Image System (2022), cited by 1

## Recent decisions
- K231702: WiScope® Digital Cystoscope System, WiScope® Single-Use Digital Flexible Cystoscope, WiScope® Medical Tablet (Sep 29, 2023)
- K220399: WiScope Digital Bronchoscope System, WiScope Single-Use Digital Flexible Bronchoscope, WiScope Image System (Jun 16, 2022)
- K212202: WiScope Digital Cystoscope System, WiScope Single-Use Digital Flexible Cystoscope, WiScope Image System (Apr 13, 2022)
- K210579: WiScope OM Endoscope System, WiScope Single-Use Digital Flexible Ureteroscope.Choledochoscope, WiScope Image System (Jul 22, 2021)
- K181977: WiScope Digital Endoscope System (Aug 14, 2018)

Source page: https://510kreport.com/company/otu-medical