# Irras USA, Inc.

- Location (FDA's records): San Diego, CA
- FDA decisions: 4 (2019–2023): 4 510(k) clearances
- Names in FDA's records: Irras USA, Inc. (2); Irras USA, Ltd. (1); Irras USA (1)
- Product codes: JXG (4)
- 510(k) review time since 2016: median 114 days, against 101 for FDA's reviews in the same codes and years (1 of 3 faster)
- Predicates its devices cite: 6 (4 its own); citations of its devices by later devices: 4 (4 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
- Irras, Inc.: 2 (https://510kreport.com/company/irras)

## Its most-cited devices
- K192289: IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit (2019), cited by 2
- K222471: IRRAflow Active Fluid Exchange System (AFES) (2022), cited by 1
- K200807: IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit (2020), cited by 1

## Recent decisions
- K231664: IRRAflow Active Fluid Exchange System (AFES) (Oct 19, 2023)
- K222471: IRRAflow Active Fluid Exchange System (AFES) (Dec 8, 2022)
- K200807: IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit (Apr 29, 2020)
- K192289: IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit (Nov 15, 2019)

Source page: https://510kreport.com/company/irras-usa