Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Avanos Medical, Inc. — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
74 daysmedian FDA review time
179 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K243572 | Game Ready system (550500-04); Game Ready Control Unit (5505 | Avanos Medical, Inc. | 2025-01-31 | 74 | 0 |
| K241185 | CORGRIP* SR NG/NI Tube Retention System | Avanos Medical, Inc. | 2024-10-25 | 179 | 0 |
| K242057 | COOLIEF* Radiofrequency Generator (CRG-BASIC, CRG-BASIC-R, C | Avanos Medical, Inc. | 2024-08-14 | 30 | 0 |
| K240965 | CORTRAK* 2 Enteral Access System (20-0950) | Avanos Medical, Inc. | 2024-06-06 | 58 | 0 |
| K220588 | Avanos* CORTRAK* 2 Enteral Access System (EAS) | Avanos Medical, Inc. | 2022-04-22 | 52 | 0 |
| K203066 | COOLIEF Cooled Radiofrequency Kit Advanced | Avanos Medical, Inc. | 2020-12-22 | 74 | 0 |
| K192491 | Coolief Radiofrequency Generator (CRG) System | Avanos Medical, Inc. | 2020-02-21 | 163 | 1 |
| K191340 | CORTRAK* 2 Equilateral Enteral Access System | Avanos Medical, Inc. | 2019-06-04 | 15 | 1 |
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