Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Industrial & Biomedical Sensors Corp. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
41 daysmedian FDA review time
42 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K802218 | SD-900 OSCILLOMETRIC BP MONITOR | Industrial & Biomedical Sensors Corp. | 1980-10-23 | 41 | 0 |
| K802202 | SD-800 BLOOD PRESSURE MONITOR | Industrial & Biomedical Sensors Corp. | 1980-10-23 | 42 | 0 |
| K802201 | SD-700 BLOOD PRESSURE MONITOR | Industrial & Biomedical Sensors Corp. | 1980-10-23 | 42 | 0 |
| K802204 | CT-1600 DIGITAL PULSE RATE MONITOR | Industrial & Biomedical Sensors Corp. | 1980-10-03 | 22 | 0 |
| K802203 | CM-700A AUTO-INFLATE CONTROL MODULE | Industrial & Biomedical Sensors Corp. | 1980-10-03 | 22 | 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