Vitalograph Ireland, Ltd.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Vitalograph Ireland, Ltd.” (first 2020, latest 2023), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 133 days. Since 2017 the median was 133 days, against 247 days for all cleared 510(k)s in the same product codes. 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 |
|---|---|---|
| 2020 | 2 | 136 |
| 2021 | 0 | — |
| 2022 | 2 | 116 |
| 2023 | 1 | 155 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Vitalograph Ireland, Ltd. took a median 133 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 247 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| BZG | Spirometer, Diagnostic | 3 | 3 |
| BTY | Calculator, Predicted Values, Pulmonary Function | 1 | 1 |
| JEH | Plethysmograph, Volume | 1 | 1 |
Review panels
- Anesthesiology (5)
Most recent Vitalograph Ireland, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K223818 | Model 9160 VitaloQUB | JEH | 2023-05-25 | 155 |
| K221030 | Model 9100 PFT/DICO | BTY | 2022-07-15 | 99 |
| K212938 | Vitalograph Model 6000 Alpha | BZG | 2022-01-26 | 133 |
| K201562 | Spirotrac | BZG | 2020-10-14 | 126 |
| K200550 | Vitalograph Model 2120 In2itive eDiary | BZG | 2020-07-27 | 146 |
Recalls
openFDA lists no recalls under a recalling firm named Vitalograph Ireland, Ltd..
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Vitalograph , Ltd. (22 510(k)s)
- Vitalograph (Ireland) , Ltd. (7 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Vitalograph Ireland, Ltd.?
FDA lists 5 510(k) clearances under the applicant name “Vitalograph Ireland, Ltd.” (first 2020, latest 2023), across 3 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 Vitalograph Ireland, Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Vitalograph Ireland, Ltd. is 133 days. Since 2017: 133 days, versus 247 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Vitalograph Ireland, Ltd.?
The most frequent FDA product codes under this applicant name are BZG (Spirometer, Diagnostic, 3); BTY (Calculator, Predicted Values, Pulmonary Function, 1); JEH (Plethysmograph, Volume, 1).
Next steps
- See all 5 Vitalograph Ireland, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code BZG, Vitalograph Ireland, Ltd.'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.