# Avanos Medical, Inc.

- Location (FDA's records): Alpharetta, GA
- FDA decisions: 8 (2019–2025): 8 510(k) clearances
- Product codes: KNT (4), GXD (2), GXI (1), IRP (1)
- 510(k) review time since 2016: median 66 days, against 118 for FDA's reviews in the same codes and years (5 of 6 faster)
- Predicates its devices cite: 5 (1 its own); citations of its devices by later devices: 1 (1 its own)
- Recalls linked to its devices: 2 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Halyard Health, Inc.: 2 (https://510kreport.com/company/halyard-health)
- Corpak Medsystems: 1 (https://510kreport.com/company/corpak-medsystems)
- Baylis Medical Co., Inc.: 1 (https://510kreport.com/company/baylis-medical)

## Its most-cited devices
- K191340: CORTRAK* 2 Equilateral Enteral Access System (2019), cited by 1

## Recent decisions
- 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 (Jan 31, 2025)
- K241185: CORGRIP* SR NG/NI Tube Retention System (Oct 25, 2024)
- K242057: COOLIEF* Radiofrequency Generator (CRG-BASIC, CRG-BASIC-R, CRG-ADVANCED, CRG-ADVANCED-R) (Aug 14, 2024)
- K240965: CORTRAK* 2 Enteral Access System (20-0950) (Jun 6, 2024)
- K220588: Avanos* CORTRAK* 2 Enteral Access System (EAS) (Apr 22, 2022)
- K203066: COOLIEF Cooled Radiofrequency Kit Advanced (Dec 22, 2020)
- K192491: Coolief Radiofrequency Generator (CRG) System (Feb 21, 2020)
- K191340: CORTRAK* 2 Equilateral Enteral Access System (Jun 4, 2019)

Source page: https://510kreport.com/company/avanos-medical