Company ยท US
Avanos Medical, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2019 to 2025. Name variants (Inc, Corp, punctuation) are merged.
8510(k) clearances (0 in 12 months)
57recalls (20 in 12 months)
37recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| KNT | Tubes, Gastrointestinal (And Accessories) | 34 |
| BSY | Catheters, Suction, Tracheobronchial | 15 |
| FRN | Pump, Infusion | 5 |
| GXD | Generator, Lesion, Radiofrequency | 3 |
| KYX | Dispenser, Liquid Medication | 3 |
| FPA | Set, Administration, Intravascular | 1 |
| GXI | Probe, Radiofrequency Lesion | 1 |
| IRP | Massager, Powered Inflatable Tube | 1 |
| KXF | Applicator, Absorbent Tipped, Non-Sterile | 1 |
| PSG | Percutaneous Endoscopic Gastrostomy Kit | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 31, 2025 | K243572 | Game Ready system (550500-04); Game Ready Control Unit (550550-04); Game Ready Full Leg Boot Wrap - Medium (590923-04); Avanos Medical, Inc. | IRP |
| Oct 25, 2024 | K241185 | CORGRIP* SR NG/NI Tube Retention System Avanos Medical, Inc. | KNT |
| Aug 14, 2024 | K242057 | COOLIEF* Radiofrequency Generator (CRG-BASIC, CRG-BASIC-R, CRG-ADVANCED, CRG-ADVANCED-R) Avanos Medical, Inc. | GXD |
| Jun 6, 2024 | K240965 | CORTRAK* 2 Enteral Access System (20-0950) Avanos Medical, Inc. | KNT |
| Apr 22, 2022 | K220588 | Avanos* CORTRAK* 2 Enteral Access System (EAS) Avanos Medical, Inc. | KNT |
| Dec 22, 2020 | K203066 | COOLIEF Cooled Radiofrequency Kit Advanced Avanos Medical, Inc. | GXI |
| Feb 21, 2020 | K192491 | Coolief Radiofrequency Generator (CRG) System Avanos Medical, Inc. | GXD |
| Jun 4, 2019 | K191340 | CORTRAK* 2 Equilateral Enteral Access System Avanos Medical, Inc. | KNT |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 5, 2026 | Avanos Medical, Inc. Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 24 Fr PULL
Model/Catalog Number: 8180-24 Open, Classified |
KNT | K924065 |
| Jun 5, 2026 | Avanos Medical, Inc. Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 20 Fr PULL
Model/Catalog Number: 8180-20 Open, Classified |
KNT | K924065 |
| Jun 5, 2026 | Avanos Medical, Inc. Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 14 Fr PULL
Model/Catalog Number: 8180-14 Open, Classified |
KNT | K924065 |
| Jun 5, 2026 | Avanos Medical, Inc. Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 24 Fr PUSH OTW
Model/Catalog Number: 8170-24 Open, Classified |
KNT | K924065 |
| Jun 5, 2026 | Avanos Medical, Inc. Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 20 Fr PUSH OTW
Model/Catalog Number: 8170-20 Open, Classified |
KNT | K924065 |
| Jun 5, 2026 | Avanos Medical, Inc. Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 14 Fr PUSH OTW
Model/Catalog Number: 8170-14
Product Description: Feeding Tube Kit
Component: No Open, Classified |
KNT | K924065 |
| Jun 5, 2026 | Avanos Medical, Inc. Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 24 Fr PULL
Model/Catalog Number: 7180-24 Open, Classified |
KNT | K924065 |
| Jun 5, 2026 | Avanos Medical, Inc. Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 20 Fr PULL
Model/Catalog Number: 7180-20 Open, Classified |
KNT | K924065 |
| Jun 5, 2026 | Avanos Medical, Inc. Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 14 Fr PULL
Model/Catalog Number: 7180-14 Open, Classified |
KNT | K924065 |
| Jun 5, 2026 | Avanos Medical, Inc. Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 24 Fr PUSH OTW
Model/Catalog Number: 7170-24
Product Description: Feeding Tube Kit
Component: No Open, Classified |
KNT | K924065 |
| Jun 5, 2026 | Avanos Medical, Inc. Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 20 Fr PUSH OTW
Model/Catalog Number: 7170-20
Product Description: Feeding Tube Kit
Component: No Open, Classified |
KNT | K924065 |
| Jun 5, 2026 | Avanos Medical, Inc. Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 14 Fr PUSH OTW
Model/Catalog Number: 7170-14
Product Description: Feeding Tube Kit Open, Classified |
KNT | K924065 |
| Jun 5, 2026 | Avanos Medical, Inc. Product Name: CORFLO Safety PEG Kit with ENFit Connector
Model/Catalog Number: 50-6316
Product Description: Feeding Tube Kit
Component: No Open, Classified |
KNT | K882867 |
| Jun 5, 2026 | Avanos Medical, Inc. Product Name: CORFLO* Safety PEG Kit with ENFit Connector
Model/Catalog Number: 50-6312 Open, Classified |
KNT | K882867 |
| Jun 5, 2026 | Avanos Medical, Inc. Product Name: CORFLO* Safety PEG Kit with ENFit Connector
Model/Catalog Number: 50-5320 Open, Classified |
KNT | K882867 |
| Jun 5, 2026 | Avanos Medical, Inc. Product Name: CORFLO* Safety PEG Kit with ENFit Connector
Model/Catalog Number: 50-4320 Open, Classified |
KNT | K882867 |
| Jun 5, 2026 | Avanos Medical, Inc. Product Name: CORFLO* Safety PEG Kit
Model/Catalog Number: 30-6316 Open, Classified |
KNT | K882867 |
| Jun 5, 2026 | Avanos Medical, Inc. Product Name: CORFLO* Safety PEG Kit
Model/Catalog Number: 30-6312 Open, Classified |
KNT | K882867 |
| Jun 5, 2026 | Avanos Medical, Inc. Brand Name: CORFLO
Product Name: CORFLO Safety PEG Kit
Model/Catalog Number: 30-5320 Open, Classified |
KNT | K882867 |
| Jun 5, 2026 | Avanos Medical, Inc. Brand Name: CORFLO
Product Name: CORFLO* Safety PEG Kit
Model/Catalog Number: 30-4320 Open, Classified |
KNT | K882867 |
| Apr 16, 2025 | Avanos Medical, Inc. Brand Name: Ballard
Product Name: Closed Suction Catheters
Model/Catalog Number: 22714183-5
Software Version: N/A
Product Description: Ballard Turbo-Cleaning Closed Suction System for Adults, 14 F, DS Open, Classified |
BSY | None listed |
| Apr 16, 2025 | Avanos Medical, Inc. Brand Name: Ballard
Product Name: Closed Suction Catheters
Model/Catalog Number: 227-5
Software Version: N/A
Product Description: Ballard Turbo-Cleaning Closed Suction System for Adults, 14 F, DSE
Com Open, Classified |
BSY | None listed |
| Apr 16, 2025 | Avanos Medical, Inc. Brand Name: Ballard
Product Name: Closed Suction Catheters
Model/Catalog Number: 2271418-5
Software Version: N/A
Product Description: Ballard Turbo-Cleaning Closed Suction System for Adults, 14 F, DSE Open, Classified |
BSY | None listed |
| Apr 16, 2025 | Avanos Medical, Inc. Brand Name: Ballard
Product Name: Closed Suction Catheters
Model/Catalog Number: 2210-5
Software Version: N/A
Product Description: Ballard Closed Suction System for Adults, 14 F, DSE
Component: N/A Open, Classified |
BSY | None listed |
| Apr 16, 2025 | Avanos Medical, Inc. Brand Name: Ballard
Product Name: Closed Suction Catheters
Model/Catalog Number: 220135
Software Version: N/A
Product Description: Ballard Closed Suction System for Adults, 14 F, T-Piece
Component: N/ Open, Classified |
BSY | None listed |
| Apr 16, 2025 | Avanos Medical, Inc. Brand Name: Ballard
Product Name: Closed Suction Catheters
Model/Catalog Number: 20083
Software Version: N/A
Product Description: Ballard Closed Suction System for Neonates/Pediatrics, 8 F, Elbow
Comp Open, Classified |
BSY | None listed |
| Apr 16, 2025 | Avanos Medical, Inc. Brand Name: Ballard
Product Name: Closed Suction Catheters
Model/Catalog Number: 210
Software Version: N/A
Product Description: Ballard Closed Suction System for Neonates/Pediatrics, 10 F, Elbow
Compo Open, Classified |
BSY | None listed |
| Apr 16, 2025 | Avanos Medical, Inc. Brand Name: Ballard
Product Name: Closed Suction Catheters
Model/Catalog Number: 198
Software Version: N/A
Product Description: Ballard Closed Suction System for Neonates/Pediatrics, 8 F, Y-Adapter
Co Open, Classified |
BSY | None listed |
| Jul 23, 2024 | Avanos Medical, Inc. MIC-KEY* Gastric-Jejunal Feeding Tube Kit, Endoscopic / Radiologic Placement, Low-Profile GJ-Tube, REF 0270xx (Non-ENFIT); and MIC-KEY* Gastric-Jejunal Feeding Tube Kit, Extension Sets with ENFit Con Open, Classified |
KNT | K922667 |
| Jun 7, 2024 | Avanos Medical, Inc. NEOMED* Pharmacy Syringes - Nonsterile (Non ENFit) with below product descriptions:
a.0.5mL Oral Syringe Orange NonSterile, Product Code BC-S05EO;
b. 12mL Oral Syringe Orange NonSterile, Product Co Open, Classified |
KYX | None listed |
| Jun 7, 2024 | Avanos Medical, Inc. NEOMED* Pharmacy Syringes - Nonsterile (Non ENFit) with below product descriptions:
a. 0.5mL Oral Syringe Blue NonSterile, Product Code BB-S05EO;
b. 12mL Oral Syringe Blue NonSterile, Product Code Open, Classified |
KYX | None listed |
| Jun 7, 2024 | Avanos Medical, Inc. NEOMED* Pharmacy Syringes - Nonsterile (Non ENFit) with below product descriptions:
a. 0.5mL Oral Syringe Amber NonSterile, Product Code BA-S05EO;
b. 12mL Oral Syringe Amber NonSterile, Product Cod Open, Classified |
KYX | None listed |
| Mar 1, 2024 | Avanos Medical, Inc. MIC* Gastric-Jejunal Feeding Tube, Endoscopic/Radiologic Placement, GJ-Tube:
a) MIC* Gastric-Jejunal Feeding Tube Kit - Endoscopic/Radiologic Placement - 16 Fr, Product Code 0250-16;
b) MIC* Gastric- Open, Classified |
KNT | K921370 |
| Mar 1, 2024 | Avanos Medical, Inc. MIC* Gastric-Jejunal Feeding Tube with ENFit Connectors:
a) MIC* Gastric-Jejunal Feeding Tube Kit with ENFit Connector - Endoscopic/Radiologic Placement - 16 Fr, Product Code 8250-16;
b) MIC* Gast Open, Classified |
KNT | K921370 |
| Nov 21, 2023 | Avanos Medical, Inc. AVANOS BALLARD Closed Suction System for Adults, 14 Fr, DSE, MDI, Product code 221038, provide suction on patients on mechanical ventilation Open, Classified |
BSY | None listed |
| Sep 21, 2023 | Avanos Medical, Inc. COOLIEF RF Generator is an 80-watt Radio-Frequency (RF) Generator with four independent RF channels, allowing all RF channels to be activated individually or altogether. The system is controlled via a Completed |
GXD | K192491 |
| Jun 6, 2023 | Avanos Medical, Inc. ambIT Cassette Filter Male Luer, Product Code: 220266 Terminated |
FRN | K162165 |
| Jun 6, 2023 | Avanos Medical, Inc. SMMT ambIT Reusable Program - Luer Cass, Product Code: 220568 Terminated |
FRN | K162165 |
| Jun 6, 2023 | Avanos Medical, Inc. SMMT ambIT Kit Basic Filter Luer Cass, Product Code: 220537 Terminated |
FRN | K162165 |
| Jun 6, 2023 | Avanos Medical, Inc. AVNS ambIT System - PIB/PCA W 5in Cath, Product Code: 220507 Terminated |
FRN | K162165 |
| Jun 6, 2023 | Avanos Medical, Inc. AVNS ambIT System - PIB/PCA W 2.5in Cath, Product Code: 220509 Terminated |
FRN | K162165 |
| Apr 19, 2023 | Avanos Medical, Inc. Avanos Ballard Oral Care Swab, Bulk Packed, Product Codes: a) 12241, b) 12243, c) 12251 Terminated |
KXF | None listed |
| Mar 13, 2023 | Avanos Medical, Inc. BALLARD* ACCESS Closed Suction System for Neonates/Pediatrics, Elbow Manifold. Terminated |
BSY | None listed |
| Mar 13, 2023 | Avanos Medical, Inc. BALLARD ACCESS Closed Suction System for Neonates/Pediatrics, Y-Manifold. Terminated |
BSY | None listed |
| Nov 8, 2022 | Avanos Medical, Inc. Y-CONNECTOR: 6" Small Kink Resistant Tubing Bifurcated Connector /2 Male Luer Locks, 1 Female Luer Lock, Labeled as: SUMMIT MEDICAL PRODUCTS, REF 220227; MPS Acacia CAT NO: BC-006-04; MEDICAL PRODUC Terminated |
FPA | None listed |
| May 13, 2022 | Avanos Medical, Inc. Avanos Cortrak 2 Enteral Access System (EAS) Terminated |
KNT | K113351 K191340 |
| Dec 22, 2021 | Avanos Medical, Inc. MIC* Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors - 20 Fr-PULL Terminated |
KNT | K924065 |
| Dec 22, 2021 | Avanos Medical, Inc. MIC* Percutaneous Endoscopic Gastrostomy PEG Kit - 20 Fr-PULL Terminated |
KNT | K924065 |
| Nov 22, 2021 | Avanos Medical, Inc. BALLARD* Multi-Access Port (MAP) Catheter, Double Swivel Y- Adult, 16 French; Sterile; Single Use Terminated |
BSY | None listed |
| Nov 22, 2021 | Avanos Medical, Inc. BALLARD* Multi-Access Port Catheter, Double Swivel Y Elbow, Adult, 14 French; Sterile; Single Use Terminated |
BSY | None listed |
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