Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Pulse Metric, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
83 daysmedian FDA review time
248 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K013478 | DYNAPULSE 5200A PATHWAY BLOOD PRESSURE MONITORING SYSTEM | Pulse Metric, Inc. | 2002-01-10 | 83 | 0 |
| K013358 | DYNAPULSE 5000A MINI ABP BLOOD PRESSURE MONITORING SYSTEM | Pulse Metric, Inc. | 2001-12-13 | 64 | 0 |
| K012498 | DYNAPULSE 500G (DP500G) BLLOD PRESSURE MONITORING SYSTEM | Pulse Metric, Inc. | 2001-11-01 | 90 | 0 |
| K945111 | DYNAPULSE 5000A (DP5000A) | Pulse Metric, Inc. | 1995-06-23 | 248 | 0 |
| K904739 | DYNAPULSE 200M | Pulse Metric, Inc. | 1991-01-08 | 82 | 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