Avanos Medical, Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Avanos Medical, Inc.” (first 2019, latest 2025), across 4 product codes in 3 review panels. Median 510(k) review time under this name: 66 days. Since 2017 the median was 66 days, against 132 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2019 | 1 | 15 |
| 2020 | 2 | 118 |
| 2021 | 0 | — |
| 2022 | 1 | 52 |
| 2023 | 0 | — |
| 2024 | 3 | 58 |
| 2025 | 1 | 74 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Avanos Medical, Inc. took a median 66 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 132 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KNT | Tubes, Gastrointestinal (And Accessories) | 4 | 4 |
| GXD | Generator, Lesion, Radiofrequency | 2 | 2 |
| GXI | Probe, Radiofrequency Lesion | 1 | 1 |
| IRP | Massager, Powered Inflatable Tube | 1 | 1 |
Review panels
Most recent Avanos Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K243572 | Game Ready system (550500-04); Game Ready Control Unit (550550-04); Game Ready Full Leg Boot Wrap - Medium (590923-04); Game Ready Full Leg Boot Wrap - Large (590922-04); Game Ready C-T Spine Wrap (590502-04); Game Ready Half Leg Boot (590906-04); Game Ready Back Wrap (590500-04); Game Ready Hand/Wrist Wrap (590811-04); Game Ready Flexed Elbow Wrap (590903-04); Game Ready Straight Elbow Wrap (590200-04); Game Ready Shoulder Wrap, Medium, Right (590422-04); Game Ready Shoulder Wrap, La | IRP | 2025-01-31 | 74 |
| K241185 | CORGRIP* SR NG/NI Tube Retention System | KNT | 2024-10-25 | 179 |
| K242057 | COOLIEF* Radiofrequency Generator (CRG-BASIC, CRG-BASIC-R, CRG-ADVANCED, CRG-ADVANCED-R) | GXD | 2024-08-14 | 30 |
| K240965 | CORTRAK* 2 Enteral Access System (20-0950) | KNT | 2024-06-06 | 58 |
| K220588 | Avanos* CORTRAK* 2 Enteral Access System (EAS) | KNT | 2022-04-22 | 52 |
| K203066 | COOLIEF Cooled Radiofrequency Kit Advanced | GXI | 2020-12-22 | 74 |
| K192491 | Coolief Radiofrequency Generator (CRG) System | GXD | 2020-02-21 | 163 |
| K191340 | CORTRAK* 2 Equilateral Enteral Access System | KNT | 2019-06-04 | 15 |
Recalls
57 product recalls in 19 recall events; 51 initiated in the last five years. Most recent: 2026-04-30.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
SEC filings
AVANOS MEDICAL, INC. (AVNS): EDGAR filings, CIK 1606498. An SEC registrant with the same name, matched by name only.
Frequently asked questions
How many FDA 510(k) clearances are listed under Avanos Medical, Inc.?
FDA lists 8 510(k) clearances under the applicant name “Avanos Medical, Inc.” (first 2019, latest 2025), across 4 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Avanos Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Avanos Medical, Inc. is 66 days. Since 2017: 66 days, versus 132 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Avanos Medical, Inc.?
The most frequent FDA product codes under this applicant name are KNT (Tubes, Gastrointestinal (And Accessories), 4); GXD (Generator, Lesion, Radiofrequency, 2); GXI (Probe, Radiofrequency Lesion, 1).
Next steps
- See all 8 Avanos Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KNT, Avanos Medical, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.