Oridion Capnography, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Oridion Capnography, Inc.” (first 2006, latest 2011), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 134 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Medtronic, based on public ownership records.
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 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DQA | Oximeter | 4 | 4 |
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | 1 | 1 |
Review panels
- Anesthesiology (5)
Most recent Oridion Capnography, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K101995 | CAPNOSTREAM 20P WITH MASIMO SPO2 BOARD | DQA | 2011-01-11 | 181 |
| K094012 | CAPNOSTREAM20 WITH MICROMEDICO2 MODULE | CCK | 2010-05-12 | 134 |
| K082268 | CAPNOSTREAM20 WITH INTEGRATED PULMONARY INDEX | DQA | 2009-02-06 | 179 |
| K072295 | CAPNOSTREAM 20 WITH A2 ADAPTIVE AVERAGING SOFTWARE | DQA | 2007-10-11 | 56 |
| K060065 | CAPNOSTREAM20 TWO PARAMETER BEDSIDE MONITOR & CAPNOSTREAM10 ONE PARAMETER BEDSIDE MONITOR | DQA | 2006-05-04 | 115 |
Recalls
2 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2007-07-28.
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.
- Oridion Medical 1987 , Ltd. (19 510(k)s)
- Oridion Medical , Ltd. (4 510(k)s)
- Oridion , Ltd. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Oridion Capnography, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Oridion Capnography, Inc.” (first 2006, latest 2011), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Oridion Capnography, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Oridion Capnography, Inc. is 134 days.
Which FDA product codes appear under Oridion Capnography, Inc.?
The most frequent FDA product codes under this applicant name are DQA (Oximeter, 4); CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase, 1).
Next steps
- See all 5 Oridion Capnography, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DQA, Oridion Capnography, 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, 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.