Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Vita-Stat Medical Services, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
19 daysmedian FDA review time
92 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K830713 | LS-1 PORTABLE BLOOD PRESSURE COMPUTER | Vita-Stat Medical Services, Inc. | 1983-06-08 | 92 | 0 |
| K830368 | AMBULATORY BLOOD PRESSURE MONITOR | Vita-Stat Medical Services, Inc. | 1983-03-31 | 55 | 0 |
| K792193 | VITA-STAT MODEL 900-D | Vita-Stat Medical Services, Inc. | 1979-11-20 | 19 | 0 |
| K792194 | VITA-STAT MODEL 900-S | Vita-Stat Medical Services, Inc. | 1979-11-20 | 19 | 0 |
| K792192 | VITA-STAT MODEL 900A | Vita-Stat Medical Services, Inc. | 1979-11-13 | 12 | 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