Pulse Metric, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Pulse Metric, Inc.” (first 1991, latest 2002), across 1 product code in 1 review panel. Median 510(k) review time under this name: 83 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
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 |
|---|---|---|---|
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 5 | 5 |
Review panels
- Cardiovascular (5)
Most recent Pulse Metric, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K013478 | DYNAPULSE 5200A PATHWAY BLOOD PRESSURE MONITORING SYSTEM | DXN | 2002-01-10 | 83 |
| K013358 | DYNAPULSE 5000A MINI ABP BLOOD PRESSURE MONITORING SYSTEM | DXN | 2001-12-13 | 64 |
| K012498 | DYNAPULSE 500G (DP500G) BLLOD PRESSURE MONITORING SYSTEM | DXN | 2001-11-01 | 90 |
| K945111 | DYNAPULSE 5000A (DP5000A) | DXN | 1995-06-23 | 248 |
| K904739 | DYNAPULSE 200M | DXN | 1991-01-08 | 82 |
Recalls
openFDA lists no recalls under a recalling firm named Pulse Metric, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Pulse Biosciences, Inc. (7 510(k)s)
- Pulse Time Products, Ltd. (6 510(k)s)
- Pulse Biomedical, Inc. (3 510(k)s)
- Pulse Scientific, Inc. (3 510(k)s)
- Pulse Life, Inc. (1 510(k)s)
- Pulse Med, Inc. (1 510(k)s)
- Pulse Medical Instruments (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Pulse Metric, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Pulse Metric, Inc.” (first 1991, latest 2002), across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Pulse Metric, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Pulse Metric, Inc. is 83 days.
Which FDA product codes appear under Pulse Metric, Inc.?
The most frequent FDA product codes under this applicant name are DXN (System, Measurement, Blood-Pressure, Non-Invasive, 5).
Next steps
- See all 5 Pulse Metric, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DXN, Pulse Metric, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.