Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Phasein AB · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
90 daysmedian FDA review time
118 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K123043 | IRMA C02 MODEL 200101; IRMA AX 200601 | Phasein AB | 2012-10-25 | 27 | 0 |
| K103604 | ISA CO2, ISA AX+, ISA OR+ | Phasein AB | 2011-04-06 | 118 | 0 |
| K081601 | VEO MULTIGAS MONITOR FOR POCKET PC | Phasein AB | 2008-09-04 | 90 | 0 |
| K072813 | EMMA ANALYZER (KPA & MMHG); EMMA MONITOR (KPA & MMHG) | Phasein AB | 2007-12-28 | 88 | 0 |
| K063167 | EMMA ANALYZER (KPA) AND (MMHG); EMMA MONITOR (KPA) AND (MMHG | Phasein AB | 2007-02-06 | 111 | 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