Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Vitalograph Ireland, Ltd. — Predicate Candidate Screening
12 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
207 daysmedian FDA review time
273 days90th percentile
12clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K223818 | Model 9160 VitaloQUB | Vitalograph Ireland, Ltd. | 2023-05-25 | 155 | 0 |
| K221030 | Model 9100 PFT/DICO | Vitalograph Ireland, Ltd. | 2022-07-15 | 99 | 0 |
| K212938 | Vitalograph Model 6000 Alpha | Vitalograph Ireland, Ltd. | 2022-01-26 | 133 | 0 |
| K201562 | Spirotrac | Vitalograph Ireland, Ltd. | 2020-10-14 | 126 | 0 |
| K200550 | Vitalograph Model 2120 In2itive eDiary | Vitalograph Ireland, Ltd. | 2020-07-27 | 146 | 0 |
| K160253 | Vitalograph Model 6300 micro | Vitalograph (Ireland) , Ltd. | 2016-08-26 | 207 | 0 |
| K142642 | Vitalograph Model 6600 Compact | Vitalograph (Ireland) , Ltd. | 2015-06-30 | 286 | 0 |
| K142812 | Vitalograph Model 6800 Pneumotrac | Vitalograph (Ireland) , Ltd. | 2015-06-29 | 273 | 0 |
| K141546 | VITALOGRAPH MODEL 7000 SPIROTRAC | Vitalograph (Ireland) , Ltd. | 2014-09-03 | 85 | 0 |
| K110525 | VITALOGRAPH MODEL 7100 - VITALOJAK | Vitalograph (Ireland) , Ltd. | 2011-11-23 | 273 | 0 |
| K100687 | VITALOGRAPH HAND HELD SPIROMETER, MODEL 2120 | Vitalograph (Ireland) , Ltd. | 2010-10-16 | 220 | 0 |
| K073155 | VITALOGRAPH MODEL 4000 (ASMA-1 AND COPD-6) | Vitalograph (Ireland) , Ltd. | 2008-06-04 | 209 | 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