Phasein AB: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Phasein AB” (first 2007, latest 2012), across 1 product code in 1 review panel. Median 510(k) review time under this name: 90 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 27 |
| 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 |
|---|---|---|---|
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | 5 | 5 |
Review panels
- Anesthesiology (5)
Most recent Phasein AB 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K123043 | IRMA C02 MODEL 200101; IRMA AX 200601 | CCK | 2012-10-25 | 27 |
| K103604 | ISA CO2, ISA AX+, ISA OR+ | CCK | 2011-04-06 | 118 |
| K081601 | VEO MULTIGAS MONITOR FOR POCKET PC | CCK | 2008-09-04 | 90 |
| K072813 | EMMA ANALYZER (KPA & MMHG); EMMA MONITOR (KPA & MMHG) | CCK | 2007-12-28 | 88 |
| K063167 | EMMA ANALYZER (KPA) AND (MMHG); EMMA MONITOR (KPA) AND (MMHG) | CCK | 2007-02-06 | 111 |
Recalls
openFDA lists no recalls under a recalling firm named Phasein AB.
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Phasein AB?
FDA lists 5 510(k) clearances under the applicant name “Phasein AB” (first 2007, latest 2012), across 1 product code 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 Phasein AB?
The median time from FDA receipt to decision across 510(k)s cleared under the name Phasein AB is 90 days.
Which FDA product codes appear under Phasein AB?
The most frequent FDA product codes under this applicant name are CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase, 5).
Next steps
- See all 5 Phasein AB clearances with predicates and recalls
- Run predicate analysis for product code CCK, Phasein AB'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.