Oridion Medical 1987 , Ltd.: FDA filings under this applicant name
FDA lists 19 510(k) clearances under the applicant name “Oridion Medical 1987 , Ltd.” (first 2001, latest 2020), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 100 days. Since 2017 the median was 249 days, against 220 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.
Caduvo groups this applicant name under Medtronic, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 2 | 244 |
| 2013 | 0 | — |
| 2014 | 1 | 610 |
| 2015 | 1 | 163 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 2 | 262 |
| 2020 | 1 | 52 |
| 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 Oridion Medical 1987 , Ltd. took a median 249 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 220 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | 17 | 17 |
| DQA | Oximeter | 1 | 1 |
| MSQ | Test, Urea (Breath Or Blood) | 1 | 1 |
Review panels
- Anesthesiology (18)
- Microbiology (1)
Most recent Oridion Medical 1987 , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K200594 | Capnostream 35 Portable Respiratory Monitor | CCK | 2020-04-27 | 52 |
| K181624 | Microstream Advance Neonatal-Infant Nasal Filter Line with O2 Tubing, Microstream Advance Pediatric Oral-Nasal Filter Line with O2 Tubing, Microstream Advance Adult Oral-Nasal Filter Line with O2 Tubing, Microstream Luer Adult Oral-Nasal Sampling Line | CCK | 2019-03-22 | 275 |
| K181467 | Microstream Luer Adult-Pediatric Intubated Sampling Line, Microstream Advance Adult-Pediatric Intubated Filter Line | CCK | 2019-02-08 | 249 |
| K150272 | Capnostream 35 Portable Respiratory Monitor | CCK | 2015-07-17 | 163 |
| K123690 | CAPNOSTREAM20P WITH HIFI C02 MONITORING | CCK | 2014-08-05 | 610 |
| K121927 | MICROSTREAM FILTERLINE ICU | CCK | 2012-11-29 | 150 |
| K112368 | CAPNOSTREAM20P WITH AI/ODI | CCK | 2012-07-19 | 337 |
| K093388 | SMART CAPNOLINE GUARDIAN | CCK | 2010-03-04 | 125 |
| K042665 | SMART BITEBLOC | CCK | 2004-11-23 | 55 |
| K024300 | MICROCAP PLUS/NPB-75 | DQA | 2003-04-03 | 100 |
9 earlier clearances. See the full list in Caduvo.
Recalls
76 product recalls in 7 recall events; 10 initiated in the last five years. Most recent: 2025-02-17.
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 Capnography, Inc. (5 510(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 Medical 1987 , Ltd.?
FDA lists 19 510(k) clearances under the applicant name “Oridion Medical 1987 , Ltd.” (first 2001, latest 2020), across 3 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 Oridion Medical 1987 , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Oridion Medical 1987 , Ltd. is 100 days. Since 2017: 249 days, versus 220 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Oridion Medical 1987 , Ltd.?
The most frequent FDA product codes under this applicant name are CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase, 17); DQA (Oximeter, 1); MSQ (Test, Urea (Breath Or Blood), 1).
Next steps
- See all 19 Oridion Medical 1987 , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code CCK, Oridion Medical 1987 , Ltd.'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.