Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Pulse Time Products, Ltd. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
130 daysmedian FDA review time
229 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K901392 | BP50 BLOOD PRESSURE AND PULSE MONITOR | Pulse Time Products, Ltd. | 1990-08-23 | 150 | 0 |
| K892795 | PULSE TIME PRODUCTS LIMITED, PM-3 | Pulse Time Products, Ltd. | 1989-08-25 | 130 | 0 |
| K892794 | PULSE TIME PRODUCTS LIMITED, PM-2 | Pulse Time Products, Ltd. | 1989-08-25 | 130 | 0 |
| K864411 | PULSE/B.P. MONITOR | Pulse Time Products, Ltd. | 1987-06-24 | 229 | 0 |
| K864748 | PM-8 HEART RATE MONITOR | Pulse Time Products, Ltd. | 1987-03-20 | 105 | 0 |
| K811425 | CARDIACMONITORS | Pulse Time Products, Ltd. | 1981-09-16 | 117 | 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