Avita Corporation: FDA filings under this applicant name
FDA lists 27 510(k) clearances under the applicant name “Avita Corporation” (first 2000, latest 2026), across 7 product codes in 6 review panels. Median 510(k) review time under this name: 168 days. Since 2017 the median was 202 days, against 175 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 |
|---|---|---|
| 2012 | 2 | 212 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 2 | 224 |
| 2019 | 0 | — |
| 2020 | 1 | 310 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 3 | 187 |
| 2025 | 2 | 179 |
| 2026 | 2 | 358 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Avita Corporation took a median 202 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 175 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FLL | Continuous Measurement Thermometer | 11 | 11 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 8 | 8 |
| DQA | Oximeter | 3 | 3 |
| BTA | Pump, Portable, Aspiration (Manual Or Powered) | 2 | 2 |
| DXQ | Blood Pressure Cuff | 1 | 1 |
| HGX | Pump, Breast, Powered | 1 | 1 |
| MNW | Analyzer, Body Composition | 1 | 1 |
Review panels
- General Hospital (11)
- Cardiovascular (9)
- Anesthesiology (3)
- General and Plastic Surgery (2)
- Gastroenterology and Urology (1)
- Obstetrics and Gynecology (1)
Most recent Avita Corporation 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K250129 | AViTA Breast Pump | HGX | 2026-06-11 | 510 |
| K252448 | AViTA Pulse Oximeter (SP61) | DQA | 2026-02-27 | 207 |
| K250765 | AViTA Arm Type Blood Pressure Monitor Cuff | DXQ | 2025-09-03 | 174 |
| K242455 | AViTA Pulse Oximeter (SP62B) | DQA | 2025-02-19 | 184 |
| K241852 | Nasal Aspirator (NS 13) | BTA | 2024-12-31 | 187 |
| K242193 | Arm Type Blood Pressure Monitor (BPM82) | DXN | 2024-10-22 | 88 |
| K223399 | AViTA Pulse Oximeter | DQA | 2024-05-20 | 558 |
| K200346 | Wrist Type Blood Pressure Monitor | DXN | 2020-12-17 | 310 |
| K180155 | Arm Type Blood Pressure Monitor | DXN | 2018-08-03 | 196 |
| K172427 | AViTA Radar Thermo NT16 Series IR Thermometer | FLL | 2018-04-19 | 252 |
17 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Avita Corporation.
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 Avita Corporation?
FDA lists 27 510(k) clearances under the applicant name “Avita Corporation” (first 2000, latest 2026), across 7 product codes in 6 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 Avita Corporation?
The median time from FDA receipt to decision across 510(k)s cleared under the name Avita Corporation is 168 days. Since 2017: 202 days, versus 175 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Avita Corporation?
The most frequent FDA product codes under this applicant name are FLL (Continuous Measurement Thermometer, 11); DXN (System, Measurement, Blood-Pressure, Non-Invasive, 8); DQA (Oximeter, 3).
Next steps
- See all 27 Avita Corporation clearances with predicates and recalls
- Run predicate analysis for product code FLL, Avita Corporation'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.