Quanta Computer, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Quanta Computer, Inc.” (first 2008, latest 2024), across 5 product codes in 3 review panels. Median 510(k) review time under this name: 214 days. Since 2017 the median was 235 days, against 176 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 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 1 | 557 |
| 2023 | 1 | 214 |
| 2024 | 1 | 235 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Quanta Computer, Inc. took a median 235 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 176 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DQA | Oximeter | 1 | 1 |
| DSH | Recorder, Magnetic Tape, Medical | 1 | 1 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 1 | 1 |
| QFM | Radiological Computer-Assisted Prioritization Software For Lesions | 1 | 1 |
| QKB | Radiological Image Processing Software For Radiation Therapy | 1 | 1 |
Review panels
- Cardiovascular (2)
- Radiology (2)
- Anesthesiology (1)
Most recent Quanta Computer, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K231855 | QOCA® image Smart RT Contouring System | QKB | 2024-02-13 | 235 |
| K221868 | QOCA image Smart CXR Image Processing System | QFM | 2023-01-27 | 214 |
| K210179 | QOCA Portable ECG Monitoring Device | DSH | 2022-08-02 | 557 |
| K083079 | QUANTA PULSE OXIMETER, MODEL: PULSE LINK 1000 OR QH100 | DQA | 2009-03-05 | 140 |
| K083078 | QUANTA BLOOD PRESSURE METER, MODEL: CARDIAC ELITE 1000 OR QH200 | DXN | 2008-11-26 | 41 |
Recalls
openFDA lists no recalls under a recalling firm named Quanta Computer, Inc..
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Quanta System Spa (57 510(k)s)
- Quanta Dialysis Technologies, Ltd. (4 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Quanta Computer, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Quanta Computer, Inc.” (first 2008, latest 2024), across 5 product codes in 3 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 Quanta Computer, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Quanta Computer, Inc. is 214 days. Since 2017: 235 days, versus 176 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Quanta Computer, Inc.?
The most frequent FDA product codes under this applicant name are DQA (Oximeter, 1); DSH (Recorder, Magnetic Tape, Medical, 1); DXN (System, Measurement, Blood-Pressure, Non-Invasive, 1).
Next steps
- See all 5 Quanta Computer, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DQA, Quanta Computer, Inc.'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.