Orantech, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Orantech, Inc.” (first 2018, latest 2019), across 5 product codes in 3 review panels. Median 510(k) review time under this name: 323 days. Since 2017 the median was 323 days, against 200 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 | 4 | 334 |
| 2019 | 1 | 156 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Orantech, Inc. took a median 323 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 200 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | 1 | 1 |
| DQA | Oximeter | 1 | 1 |
| DSA | Cable, Transducer And Electrode, Patient, (Including Connector) | 1 | 1 |
| DXQ | Blood Pressure Cuff | 1 | 1 |
| FLL | Continuous Measurement Thermometer | 1 | 1 |
Review panels
- Anesthesiology (2)
- Cardiovascular (2)
- General Hospital (1)
Most recent Orantech, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K182327 | Patient Cables and Leadwires , Disposable ECG Leadwires | DSA | 2019-01-30 | 156 |
| K173194 | Temperature Probe | FLL | 2018-10-10 | 373 |
| K181270 | Disposable SpO2 Sensors, Reusable SpO2 Sensors | DQA | 2018-09-07 | 116 |
| K173197 | Reusable NIBP Cuff | DXQ | 2018-08-21 | 323 |
| K171828 | ETCO2 Sensor | CCK | 2018-05-31 | 345 |
Recalls
openFDA lists no recalls under a recalling firm named Orantech, 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Orantech, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Orantech, Inc.” (first 2018, latest 2019), 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 Orantech, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Orantech, Inc. is 323 days. Since 2017: 323 days, versus 200 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Orantech, Inc.?
The most frequent FDA product codes under this applicant name are CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase, 1); DQA (Oximeter, 1); DSA (Cable, Transducer And Electrode, Patient, (Including Connector), 1).
Next steps
- See all 5 Orantech, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CCK, Orantech, 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.