Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Oridion Capnography, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
134 daysmedian FDA review time
181 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K101995 | CAPNOSTREAM 20P WITH MASIMO SPO2 BOARD | Oridion Capnography, Inc. | 2011-01-11 | 181 | 0 |
| K094012 | CAPNOSTREAM20 WITH MICROMEDICO2 MODULE | Oridion Capnography, Inc. | 2010-05-12 | 134 | 0 |
| K082268 | CAPNOSTREAM20 WITH INTEGRATED PULMONARY INDEX | Oridion Capnography, Inc. | 2009-02-06 | 179 | 0 |
| K072295 | CAPNOSTREAM 20 WITH A2 ADAPTIVE AVERAGING SOFTWARE | Oridion Capnography, Inc. | 2007-10-11 | 56 | 0 |
| K060065 | CAPNOSTREAM20 TWO PARAMETER BEDSIDE MONITOR & CAPNOSTREAM10 | Oridion Capnography, Inc. | 2006-05-04 | 115 | 3 |
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