Vitalograph (Ireland) , Ltd.: FDA clearances and approvals
Vitalograph (Ireland) , Ltd. has 7 FDA 510(k) clearances (first 2008, latest 2016), across 2 product codes in 2 review panels. Median 510(k) review time: 220 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 1 | 85 |
| 2015 | 2 | 280 |
| 2016 | 1 | 207 |
| 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 | 6 | 6 |
| DSH | Recorder, Magnetic Tape, Medical | 1 | 1 |
Review panels
- Anesthesiology (6)
- Cardiovascular (1)
Most recent Vitalograph (Ireland) , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K160253 | Vitalograph Model 6300 micro | BZG | 2016-08-26 | 207 |
| K142642 | Vitalograph Model 6600 Compact | BZG | 2015-06-30 | 286 |
| K142812 | Vitalograph Model 6800 Pneumotrac | BZG | 2015-06-29 | 273 |
| K141546 | VITALOGRAPH MODEL 7000 SPIROTRAC | BZG | 2014-09-03 | 85 |
| K110525 | VITALOGRAPH MODEL 7100 - VITALOJAK | DSH | 2011-11-23 | 273 |
| K100687 | VITALOGRAPH HAND HELD SPIROMETER, MODEL 2120 | BZG | 2010-10-16 | 220 |
| K073155 | VITALOGRAPH MODEL 4000 (ASMA-1 AND COPD-6) | BZG | 2008-06-04 | 209 |
Recalls
openFDA lists no recalls under a recalling firm named Vitalograph (Ireland) , Ltd..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Vitalograph (Ireland) , Ltd. have?
Vitalograph (Ireland) , Ltd. has 7 FDA 510(k) clearances (first 2008, latest 2016), across 2 product codes in 2 review panels.
How long does FDA take to clear Vitalograph (Ireland) , Ltd.'s 510(k)s?
The median time from FDA receipt to decision across Vitalograph (Ireland) , Ltd.'s cleared 510(k)s is 220 days.
What devices does Vitalograph (Ireland) , Ltd. make?
Its most frequent FDA product codes are BZG (Spirometer, Diagnostic, 6); DSH (Recorder, Magnetic Tape, Medical, 1).
Has Vitalograph (Ireland) , Ltd. had device recalls?
openFDA lists no recalls under a recalling firm name matching Vitalograph (Ireland) , Ltd. Related entities may recall under other names.
Next steps
- See all 7 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. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.