510(k) Report

FDA applicant

Avanos Medical, Inc.

Alpharetta, GA8 decisions2019–20252 recalls

FDA records 8 decisions for Avanos Medical, Inc. (Alpharetta, GA) from 2019 to 2025: 8 510(k) clearances. Most are in product codes KNT (Tubes, Gastrointestinal (And Accessories)) and GXD (Generator, Lesion, Radiofrequency). Since 2016 its 510(k)s took a median of 66 days from receipt to decision, against 118 for FDA’s reviews in the same codes and years. Its devices cite 5 predicates, 1 of them its own earlier devices. 2 recalls are linked to its devices, 1 Class I.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, gastroenterology and urology panel, where it files most

How often FDA has decided Avanos Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2019: 12020: 22022: 12024: 32025: 1
2019high 3 (2024) · low 0 (2021)2026

2026 so far, outlined.

Recalls per year

1in 2023

2022: 1, 1 Class I2023: 1
2019high 1 (2022) · low 0 (2019)2026

Class I Class II/III not classified

FIG. 1 — Avanos Medical, Inc. by year, 2019–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Avanos Medical, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • KNTTubes, Gastrointestinal (And Accessories)4decisions
  • GXDGenerator, Lesion, Radiofrequency2decisions
  • GXIProbe, Radiofrequency Lesion1decision
  • IRPMassager, Powered Inflatable Tube1decision

How long do its 510(k) reviews take?

Since 2016, its 6 510(k)s took a median of 66 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 118 days; 5 of its 6 were faster than that.

Whose devices does it build on?

Its devices cite 5 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K191340CORTRAK* 2 Equilateral Enteral Access SystemAvanos Medical, Inc. · 20191cites it

What has FDA decided for it lately?

  • K243572Game Ready system (550500-04); Game Ready Control Unit (550550-04); Game Ready Full Leg Boot Wrap - Medium…Avanos Medical, Inc. · 2025
  • K241185CORGRIP* SR NG/NI Tube Retention SystemAvanos Medical, Inc. · 2024
  • K242057COOLIEF* Radiofrequency Generator (CRG-BASIC, CRG-BASIC-R, CRG-ADVANCED, CRG-ADVANCED-R)Avanos Medical, Inc. · 2024
  • K240965CORTRAK* 2 Enteral Access System (20-0950)Avanos Medical, Inc. · 2024
  • K220588Avanos* CORTRAK* 2 Enteral Access System (EAS)Avanos Medical, Inc. · 2022
  • K203066COOLIEF Cooled Radiofrequency Kit AdvancedAvanos Medical, Inc. · 2020
  • K192491Coolief Radiofrequency Generator (CRG) SystemAvanos Medical, Inc. · 20201 recall
  • K191340CORTRAK* 2 Equilateral Enteral Access SystemAvanos Medical, Inc. · 20191 Class I recall

All 8 as Avanos Medical, Inc. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K192491COOLIEF RF Generator is an 80-watt Radio-Frequency (RF) Generator with four independent…Aug 1, 2023Class II
  • K191340Avanos Cortrak 2 Enteral Access System (EAS)Mar 21, 2022Class I