Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Gereonics, Inc. — 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) |
|---|---|---|---|---|---|
| K062883 | GEREONICS ULTRA-PIEZO LIMB MOVEMENT SENSOR | Gereonics, Inc. | 2007-06-13 | 260 | 0 |
| K991411 | GEREONICS ULTRA-PIEZO RESPIRATORY EFFORT SENSOR | Gereonics, Inc. | 1999-04-28 | 33 | 0 |
| K983449 | GEREONICS ULTRA-PIEZO RESPIRATORY EFFORT SENSOR | Gereonics, Inc. | 1999-02-08 | 131 | 0 |
| K861099 | GEREONICS BIOPOTENTIAL SKIN ELECTRODES | Gereonics, Inc. | 1986-08-06 | 135 | 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