Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Zephyr Technology Corporation — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K122763 | PHYSIOLOGICAL DATA PROCESSOR | Zephyr Technology Corporation | 2013-06-20 | 283 | 0 |
| K123658 | BIOMODULE 3-M1 | Zephyr Technology Corporation | 2013-04-24 | 147 | 0 |
| K113045 | BIOHARNESS | Zephyr Technology Corporation | 2012-08-14 | 306 | 0 |
| K100040 | BIOHARNESS | Zephyr Technology Corporation | 2010-12-03 | 330 | 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