# Otodynamics, Ltd.

- Location (FDA's records): Crofton, MD
- FDA decisions: 8 (1997–2024): 8 510(k) clearances
- Names in FDA's records: Otodynamics, Ltd. (7); Otodynamics (1)
- Product codes: EWO (8)
- Predicates its devices cite: 7 (5 its own); citations of its devices by later devices: 11 (5 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
- Everest Biomedical Instruments Co.: 1 (https://510kreport.com/company/everest-biomedical-instruments)
- Gn Otometrics: 1 (https://510kreport.com/company/gn-otometrics)

## Firms that cite its devices most
- Natus Medical, Inc.: 2 (https://510kreport.com/company/natus-medical)
- Fischer-Zoth Audiologic Systems, Inc.: 1 (https://510kreport.com/company/fischer-zoth-audiologic-systems)
- Bio-Logic Systems Corp.: 1 (https://510kreport.com/company/bio-logic-systems)
- Hearx SA (Pty), Ltd.: 1 (https://510kreport.com/company/hearx)
- Intelligent Hearing Systems: 1 (https://510kreport.com/company/intelligent-hearing-systems)

## Its most-cited devices
- K072033: Otodynamics Otoport (2007), cited by 4
- K983350: ILO292 DP Echoport Plus Oae System (1998), cited by 2
- K143395: Otoport OAE +ABR Advance, Otoport OAE+ABR DP+TE, Otoport OAE+ABR Screener-Otocheck OAE+ABR, Otocheck OAE+ABR LE, Otocheck ABR Screener-Otodynamics ABR Upgrade Kit (2015), cited by 2
- K962995: ILO88. Otodynamic Analyser, Kit System for PC (1997), cited by 2
- K983352: ILO2088 Enchocheck or ILO2088 Otocheck (1998), cited by 1

## Recent decisions
- K234095: OtoNova/OtoNova Pro (Jun 21, 2024)
- K240430: Otoport Pro (Mar 15, 2024)
- K143395: Otoport OAE +ABR Advance, Otoport OAE+ABR DP+TE, Otoport OAE+ABR Screener-Otocheck OAE+ABR, Otocheck OAE+ABR LE, Otocheck ABR Screener-Otodynamics ABR Upgrade Kit (Feb 23, 2015)
- K072033: Otodynamics Otoport (Nov 13, 2007)
- K983350: ILO292 DP Echoport Plus Oae System (Dec 11, 1998)
- K983351: ILO292 DP Echoport Plus Oae System (Dec 11, 1998)
- K983352: ILO2088 Enchocheck or ILO2088 Otocheck (Dec 11, 1998)
- K962995: ILO88. Otodynamic Analyser, Kit System for PC (Jan 10, 1997)

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