Wallaby Medical: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Wallaby Medical” (first 2018, latest 2026), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 183 days. Since 2017 the median was 183 days, against 118 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2018 | 1 | 151 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 1 | 166 |
| 2022 | 0 | — |
| 2023 | 3 | 185 |
| 2024 | 2 | 256 |
| 2025 | 0 | — |
| 2026 | 1 | 243 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Wallaby Medical took a median 183 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 118 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DQY | Catheter, Percutaneous | 2 | 2 |
| NRY | Catheter, Thrombus Retriever | 2 | 2 |
| QJP | Catheter, Percutaneous, Neurovasculature | 2 | 2 |
| HCG | Device, Neurovascular Embolization | 1 | 1 |
| KRA | Catheter, Continuous Flush | 1 | 1 |
Review panels
- Neurology (5)
- Cardiovascular (3)
Most recent Wallaby Medical 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K254071 | p17 XR Microcatheter | QJP | 2026-08-18 | 243 |
| K240917 | Esperance 3+ Aspiration Catheter System | NRY | 2024-10-01 | 181 |
| K231056 | Esperance Distal Access Catheter | QJP | 2024-03-08 | 330 |
| K232437 | Paragon 8F Balloon Guide Catheter | DQY | 2023-10-13 | 60 |
| K223139 | Wallaby 017 Micro Catheter | KRA | 2023-04-25 | 203 |
| K222603 | 6F Wallaby Long Sheath | DQY | 2023-03-02 | 185 |
| K211697 | Esperance Aspiration Catheter System | NRY | 2021-11-16 | 166 |
| K173711 | Wallaby Avenir Coil System | HCG | 2018-05-04 | 151 |
Recalls
openFDA lists no recalls under a recalling firm named Wallaby Medical.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Wallaby Medical?
FDA lists 8 510(k) clearances under the applicant name “Wallaby Medical” (first 2018, latest 2026), across 5 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Wallaby Medical?
The median time from FDA receipt to decision across 510(k)s cleared under the name Wallaby Medical is 183 days. Since 2017: 183 days, versus 118 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Wallaby Medical?
The most frequent FDA product codes under this applicant name are DQY (Catheter, Percutaneous, 2); NRY (Catheter, Thrombus Retriever, 2); QJP (Catheter, Percutaneous, Neurovasculature, 2).
Next steps
- See all 8 Wallaby Medical clearances with predicates and recalls
- Run predicate analysis for product code DQY, Wallaby Medical's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.