Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Geon Corporation · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K243138 | Geon (S2) Nasal Aspirator | Geon Corporation | 2025-02-04 | 127 | 0 |
| K220126 | Geonic Nasal Aspirator, Geonic Nasal Cleaner | Geon Corporation | 2023-02-02 | 380 | 0 |
| K100563 | GEON RAPID DIGITAL THERMOMETER MODEL: MT-B117, MT-B127, MT-B | Geon Corporation | 2010-06-02 | 93 | 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