Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Healthstats International Pte. , Ltd. · Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
62 daysmedian FDA review time
266 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K173028 | BPro BT Ambulatory Blood Pressure Monitoring System with BPr | Healthstats International Pte. , Ltd. | 2018-06-21 | 266 | 0 |
| K131916 | BPROSOFT CASP PC SOFTWARE | Healthstats International Pte. , Ltd. | 2014-03-11 | 258 | 0 |
| K131788 | HEALTHSTATS A-PULSE CASPAL + AND MC3100+ MONITORS AND MY-BP | Healthstats International Pte. , Ltd. | 2014-03-04 | 259 | 0 |
| K101002 | A-PULSE CASPRO MODEL T7100, A-PULSE CASPAL MODEL T7200 | Healthstats International Pte. , Ltd. | 2010-06-08 | 57 | 0 |
| K072593 | A-PLUS ARTERIAL PULSE WAVEFORM ANALYSIS SYSTEM AND PC SOFTWA | Healthstats International Pte. , Ltd. | 2007-11-15 | 62 | 0 |
| K060315 | HEALTHSTATS BPRO AMBULATORY BLOOD PRESSURE MONITORING SYSTEM | Healthstats International Pte. , Ltd. | 2006-04-07 | 58 | 0 |
| K051546 | BPCALIBRATOR MC3000/MC3100 | Healthstats International Pte. , Ltd. | 2005-06-24 | 11 | 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