# Wallaby Medical

- Location (FDA's records): Laguna Hills, CA
- FDA decisions: 8 (2018–2026): 8 510(k) clearances
- Names in FDA's records: Wallaby Medical (6); Wallaby Medical, Inc. (2)
- Product codes: NRY (2), DQY (2), QJP (2), HCG (1), KRA (1)
- 510(k) review time since 2016: median 183 days, against 128 for FDA's reviews in the same codes and years (2 of 8 faster)
- Predicates its devices cite: 9 (0 its own); citations of its devices by later devices: 1 (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 whose devices it cites most
- Penumbra, Inc.: 4 (https://510kreport.com/company/penumbra)
- Micro Therapeutics, Inc. d/b/a ev3 Neurovascular: 2 (https://510kreport.com/company/micro-therapeutics-d-b-a-ev3-neurovascular)
- Concentric Medical, Inc.: 1 (https://510kreport.com/company/concentric-medical)
- Medos International SARL: 1 (https://510kreport.com/company/medos-international)
- MicroVention, Inc.: 1 (https://510kreport.com/company/microvention)

## Firms that cite its devices most
- Phenox Limited: 1 (https://510kreport.com/company/phenox)

## Its most-cited devices
- K211697: Esperance Aspiration Catheter System (2021), cited by 1

## Recent decisions
- K254071: p17 XR Microcatheter (Aug 18, 2026)
- K240917: Esperance 3+ Aspiration Catheter System (Oct 1, 2024)
- K231056: Esperance Distal Access Catheter (Mar 8, 2024)
- K232437: Paragon 8F Balloon Guide Catheter (Oct 13, 2023)
- K223139: Wallaby 017 Micro Catheter (Apr 25, 2023)
- K222603: 6F Wallaby Long Sheath (Mar 2, 2023)
- K211697: Esperance Aspiration Catheter System (Nov 16, 2021)
- K173711: Wallaby Avenir Coil System (May 4, 2018)

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