# Custom Ultrasonics

- Location (FDA's records): Ivyland, PA
- FDA decisions: 6 (1984–2020): 6 510(k) clearances
- Names in FDA's records: Custom Ultrasonics (4); Custom Ultrasonics, Inc. (2)
- Product codes: FEB (4), NVE (1), FLG (1)
- Predicates its devices cite: 2 (1 its own); citations of its devices by later devices: 4 (1 its own)
- Recalls linked to its devices: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Psk Connectors Pty, Ltd.: 1 (https://510kreport.com/company/psk-connectors)

## Firms that cite its devices most
- Langford IC Systems, Inc.: 2 (https://510kreport.com/company/langford-ic-systems)
- Wassenburg Medical, Inc.: 1 (https://510kreport.com/company/wassenburg-medical)

## Its most-cited devices
- K983017: Modification to System 83 Plus (1998), cited by 2
- K173590: System 83 Plus Washer/Disinfector (2020), cited by 1
- K122172: System 83 Plus (2013), cited by 1

## Recent decisions
- K173590: System 83 Plus Washer/Disinfector (Mar 30, 2020)
- K162120: Scope-Assist Flushing Sink (Apr 28, 2017)
- K122172: System 83 Plus (Jan 25, 2013)
- K061430: System 83 Plus Miniflex Washer-Disinfector (Jan 12, 2007)
- K983017: Modification to System 83 Plus (Sep 22, 1998)
- K842754: Custom Ultrasonics-Sys 80, 81-24, 83-2 (Nov 28, 1984)

Source page: https://510kreport.com/company/custom-ultrasonics