Pulse Time Products, Ltd.: FDA clearances and approvals
Pulse Time Products, Ltd. has 6 FDA 510(k) clearances (first 1981, latest 1990), across 2 product codes in 1 review panel. Median 510(k) review time: 130 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | 4 | 4 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 2 | 2 |
Review panels
- Cardiovascular (6)
Most recent Pulse Time Products, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K901392 | BP50 BLOOD PRESSURE AND PULSE MONITOR | DXN | 1990-08-23 | 150 |
| K892795 | PULSE TIME PRODUCTS LIMITED, PM-3 | DRT | 1989-08-25 | 130 |
| K892794 | PULSE TIME PRODUCTS LIMITED, PM-2 | DRT | 1989-08-25 | 130 |
| K864411 | PULSE/B.P. MONITOR | DXN | 1987-06-24 | 229 |
| K864748 | PM-8 HEART RATE MONITOR | DRT | 1987-03-20 | 105 |
| K811425 | CARDIACMONITORS | DRT | 1981-09-16 | 117 |
Recalls
openFDA lists no recalls under a recalling firm named Pulse Time Products, Ltd..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Pulse Time Products, Ltd. have?
Pulse Time Products, Ltd. has 6 FDA 510(k) clearances (first 1981, latest 1990), across 2 product codes in 1 review panel.
How long does FDA take to clear Pulse Time Products, Ltd.'s 510(k)s?
The median time from FDA receipt to decision across Pulse Time Products, Ltd.'s cleared 510(k)s is 130 days.
What devices does Pulse Time Products, Ltd. make?
Its most frequent FDA product codes are DRT (Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm), 4); DXN (System, Measurement, Blood-Pressure, Non-Invasive, 2).
Has Pulse Time Products, Ltd. had device recalls?
openFDA lists no recalls under a recalling firm name matching Pulse Time Products, Ltd. Related entities may recall under other names.
Next steps
- See all 6 Pulse Time Products, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code DRT, Pulse Time Products, Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.