Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Oridion Medical 1987 , Ltd. — Predicate Candidate Screening
19 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
100 daysmedian FDA review time
337 days90th percentile
19clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K200594 | Capnostream 35 Portable Respiratory Monitor | Oridion Medical 1987 , Ltd. | 2020-04-27 | 52 | 0 |
| K181624 | Microstream Advance Neonatal-Infant Nasal Filter Line with O | Oridion Medical 1987 , Ltd. | 2019-03-22 | 275 | 0 |
| K181467 | Microstream Luer Adult-Pediatric Intubated Sampling Line, Mi | Oridion Medical 1987 , Ltd. | 2019-02-08 | 249 | 11 |
| K150272 | Capnostream 35 Portable Respiratory Monitor | Oridion Medical 1987 , Ltd. | 2015-07-17 | 163 | 0 |
| K123690 | CAPNOSTREAM20P WITH HIFI C02 MONITORING | Oridion Medical 1987 , Ltd. | 2014-08-05 | 610 | 1 |
| K121927 | MICROSTREAM FILTERLINE ICU | Oridion Medical 1987 , Ltd. | 2012-11-29 | 150 | 0 |
| K112368 | CAPNOSTREAM20P WITH AI/ODI | Oridion Medical 1987 , Ltd. | 2012-07-19 | 337 | 0 |
| K093388 | SMART CAPNOLINE GUARDIAN | Oridion Medical 1987 , Ltd. | 2010-03-04 | 125 | 1 |
| K042665 | SMART BITEBLOC | Oridion Medical 1987 , Ltd. | 2004-11-23 | 55 | 2 |
| K024300 | MICROCAP PLUS/NPB-75 | Oridion Medical 1987 , Ltd. | 2003-04-03 | 100 | 0 |
| K013845 | MODIFICATION TO: MAC-LINE O2/CO2 ORAL NASAL CANNULA SAMPLE L | Oridion Medical 1987 , Ltd. | 2001-11-29 | 9 | 2 |
| K011536 | MICROSTREAM O2/CO2 ORAL NASAL FILTERLINE | Oridion Medical 1987 , Ltd. | 2001-11-14 | 180 | 7 |
| K012395 | MAC-LINE 02/CO2 NASAL CANNULA SAMPLE LINE | Oridion Medical 1987 , Ltd. | 2001-08-15 | 19 | 3 |
| K012391 | MAC-LINE CO2 NASAL CANNULA SAMPLE LINE | Oridion Medical 1987 , Ltd. | 2001-08-15 | 19 | 3 |
| K012394 | ORIDION MAC-LINE ORAL NASAL CANNULA SAMPLE LINE | Oridion Medical 1987 , Ltd. | 2001-08-15 | 19 | 0 |
| K011668 | VALIDATION OF THE BREATHID SYSTEM, FOR THE DETECTION OF HELI | Oridion Medical 1987 , Ltd. | 2001-07-09 | 53 | 0 |
| K011050 | MICROSTREAM ORAL NASAL CANNULA FILTERLINE | Oridion Medical 1987 , Ltd. | 2001-05-04 | 28 | 3 |
| K010024 | O2/CO2 NASAL FILTERLINE | Oridion Medical 1987 , Ltd. | 2001-03-14 | 70 | 3 |
| K002163 | MICROSTREAM EXTERNAL BATTERY CHARGER | Oridion Medical 1987 , Ltd. | 2001-01-11 | 177 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda