Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Vitalograph , Ltd. — Predicate Candidate Screening
17 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
98 daysmedian FDA review time
309 days90th percentile
17clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253293 | VitaloJAK Clinic (Model 7100) | Vitalograph , Ltd. | 2025-12-03 | 65 | 0 |
| K950854 | VITALOGRAPH 2110 SOFTWARE INTERFACE | Vitalograph , Ltd. | 1995-10-12 | 227 | 0 |
| K925085 | ESCORT SPIROMETER | Vitalograph , Ltd. | 1993-08-12 | 309 | 0 |
| K930085 | VITALOGRAPH DATA STORAGE SPIROMETER | Vitalograph , Ltd. | 1993-07-26 | 200 | 0 |
| K912412 | VITALOGRAPH SPIROTRAC III | Vitalograph , Ltd. | 1991-10-15 | 137 | 0 |
| K893665 | AEROSOL INHALATION MONITOR | Vitalograph , Ltd. | 1989-08-21 | 98 | 0 |
| K892524 | VITALOGRAPH-BREATHCO MONITOR | Vitalograph , Ltd. | 1989-05-05 | 24 | 0 |
| K873562 | VITALOGRAPH-ALPHA | Vitalograph , Ltd. | 1988-08-29 | 362 | 0 |
| K874892 | VITALOGRAPH-EC60 HYDROGEN MONITOR | Vitalograph , Ltd. | 1988-06-02 | 184 | 0 |
| K863420 | VITALOGRAPH EC-50 CARBON MONOXIDE MONITOR | Vitalograph , Ltd. | 1987-01-15 | 133 | 0 |
| K860949 | DUAL-AID | Vitalograph , Ltd. | 1986-05-06 | 55 | 0 |
| K854526 | VITALOGRAPH COMPACT | Vitalograph , Ltd. | 1985-12-24 | 41 | 0 |
| K844963 | VITAPEP | Vitalograph , Ltd. | 1985-06-07 | 165 | 0 |
| K833785 | EMERGENCY ASPIRATOR | Vitalograph , Ltd. | 1983-12-22 | 55 | 0 |
| K823683 | VITALOGRAPH PFT PRINTER | Vitalograph , Ltd. | 1983-01-21 | 45 | 0 |
| K791503 | VITALOGRAPH FUNCTION ANALYZER | Vitalograph , Ltd. | 1979-08-16 | 8 | 0 |
| K781922 | PULMONARY MONITOR | Vitalograph , Ltd. | 1979-02-13 | 92 | 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