Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Exalenz Bioscience , Ltd. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
86 daysmedian FDA review time
90 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K193610 | BreathID Smart System | Exalenz Bioscience , Ltd. | 2020-02-06 | 42 | 0 |
| K173772 | BreathID Hp System | Exalenz Bioscience , Ltd. | 2018-03-08 | 86 | 0 |
| K173777 | BreathID Hp Lab System | Exalenz Bioscience , Ltd. | 2018-03-08 | 86 | 0 |
| K162150 | BreathID Hp Lab System | Exalenz Bioscience , Ltd. | 2016-10-31 | 90 | 0 |
| K130524 | BREATHID HP SYSTEM | Exalenz Bioscience , Ltd. | 2013-05-22 | 83 | 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