Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Orantech, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
323 daysmedian FDA review time
373 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K182327 | Patient Cables and Leadwires , Disposable ECG Leadwires | Orantech, Inc. | 2019-01-30 | 156 | 0 |
| K173194 | Temperature Probe | Orantech, Inc. | 2018-10-10 | 373 | 0 |
| K181270 | Disposable SpO2 Sensors, Reusable SpO2 Sensors | Orantech, Inc. | 2018-09-07 | 116 | 0 |
| K173197 | Reusable NIBP Cuff | Orantech, Inc. | 2018-08-21 | 323 | 0 |
| K171828 | ETCO2 Sensor | Orantech, Inc. | 2018-05-31 | 345 | 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