Healthstats International Pte. , Ltd.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Healthstats International Pte. , Ltd.” (first 2005, latest 2018), across 1 product code in 1 review panel. Median 510(k) review time under this name: 62 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 | 2 | 258 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 1 | 266 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Healthstats International Pte. , Ltd. took a median 266 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 162 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 7 | 7 |
Review panels
- Cardiovascular (7)
Most recent Healthstats International Pte. , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K173028 | BPro BT Ambulatory Blood Pressure Monitoring System with BProSoft BT PC Software | DXN | 2018-06-21 | 266 |
| K131916 | BPROSOFT CASP PC SOFTWARE | DXN | 2014-03-11 | 258 |
| K131788 | HEALTHSTATS A-PULSE CASPAL + AND MC3100+ MONITORS AND MY-BP BP MANAGEMENT APPLICATION SOFTWARE | DXN | 2014-03-04 | 259 |
| K101002 | A-PULSE CASPRO MODEL T7100, A-PULSE CASPAL MODEL T7200 | DXN | 2010-06-08 | 57 |
| K072593 | A-PLUS ARTERIAL PULSE WAVEFORM ANALYSIS SYSTEM AND PC SOFTWARE | DXN | 2007-11-15 | 62 |
| K060315 | HEALTHSTATS BPRO AMBULATORY BLOOD PRESSURE MONITORING SYSTEM | DXN | 2006-04-07 | 58 |
| K051546 | BPCALIBRATOR MC3000/MC3100 | DXN | 2005-06-24 | 11 |
Recalls
openFDA lists no recalls under a recalling firm named Healthstats International Pte. , Ltd..
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Healthstats International Pte. , Ltd.?
FDA lists 7 510(k) clearances under the applicant name “Healthstats International Pte. , Ltd.” (first 2005, latest 2018), 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 Healthstats International Pte. , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Healthstats International Pte. , Ltd. is 62 days.
Which FDA product codes appear under Healthstats International Pte. , Ltd.?
The most frequent FDA product codes under this applicant name are DXN (System, Measurement, Blood-Pressure, Non-Invasive, 7).
Next steps
- See all 7 Healthstats International Pte. , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code DXN, Healthstats International Pte. , Ltd.'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.