Mir Medical Intl. Research Srl: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Mir Medical Intl. Research Srl” (first 1998, latest 2013), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 163 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 | 59 |
| 2013 | 1 | 223 |
| 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 |
|---|---|---|---|
| BZG | Spirometer, Diagnostic | 9 | 9 |
| DQA | Oximeter | 1 | 1 |
Review panels
- Anesthesiology (10)
Most recent Mir Medical Intl. Research Srl 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K130784 | SPIROTEL | BZG | 2013-10-30 | 223 |
| K122384 | MINISPIR | BZG | 2012-10-04 | 59 |
| K081033 | MIROXI | DQA | 2009-01-15 | 279 |
| K082766 | MODIFICATION TO MINISPIR, SPIROLAB III | BZG | 2008-12-17 | 86 |
| K072979 | SPIROBANK G | BZG | 2007-12-26 | 65 |
| K061875 | MINISPIR; SPIROLAB III | BZG | 2006-12-11 | 161 |
| K061712 | SPIROBANK II | BZG | 2006-12-01 | 165 |
| K052140 | SPIROLAB, SPIROLAB II | BZG | 2006-03-16 | 220 |
| K043528 | SPIROTEL | BZG | 2005-07-19 | 210 |
| K983909 | MIR SPIROBANK SPIROMETER | BZG | 1998-12-21 | 48 |
Recalls
openFDA lists no recalls under a recalling firm named Mir Medical Intl. Research Srl.
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 Mir Medical Intl. Research Srl?
FDA lists 10 510(k) clearances under the applicant name “Mir Medical Intl. Research Srl” (first 1998, latest 2013), across 2 product codes 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 Mir Medical Intl. Research Srl?
The median time from FDA receipt to decision across 510(k)s cleared under the name Mir Medical Intl. Research Srl is 163 days.
Which FDA product codes appear under Mir Medical Intl. Research Srl?
The most frequent FDA product codes under this applicant name are BZG (Spirometer, Diagnostic, 9); DQA (Oximeter, 1).
Next steps
- See all 10 Mir Medical Intl. Research Srl clearances with predicates and recalls
- Run predicate analysis for product code BZG, Mir Medical Intl. Research Srl'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.