Home / 510(k) Clearances / K220955

510(k) K220955

Hudson RCI Variable concentration Large Volume Nebulizer (1770) by Medline Industires, Inc. — Product Code CAF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 23, 2023
Date Received
April 1, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Nebulizer (Direct Patient Interface)
Device Class
Class II
Regulation Number
868.5630
Review Panel
AN
Submission Type

Other clearances by Medline Industires, Inc.

  • K234031 — Medline UNITE Ancillary Foot Recon Plating System (January 18, 2024)
  • K201129 — Medline Smoke Evacuation Pencil (October 16, 2020)
  • K201390 — Medline Powder-Free Light Blue Nitrile Exam Gloves (Tested for Use with Chemothe (September 18, 2020)
  • K200960 — Medline Powder Free Examination Gloves (Tested for use with Chemotherapy Drugs) (July 13, 2020)
  • K201319 — Medline UNITE Jones Fracture Screw System (June 17, 2020)

Other clearances for product code CAF

  • K251572 — eRapid with eTrack System (December 19, 2025)
  • K251659 — Mesh Nebulizer (H6) (November 14, 2025)
  • K244035 — Portable mesh nebulizer (JM821) (September 19, 2025)
  • K243468 — Compressor Nebulizer (NB-1100); Compressor Nebulizer (NB-1101); Compressor Nebul (July 2, 2025)
  • K250022 — HeroTracker Sense (June 30, 2025)
  • K250583 — AdheResp Smart Breath-actuated Mesh Nebulizer (June 20, 2025)
  • K242354 — AllNEB (April 29, 2025)
  • K233553 — MiniSpacer® 1024, 1025, 1543 and 1024A, 1025A, 1543A Dual Spray MDI Adapter (June 18, 2024)
  • K232507 — Aerogen®Solo Nebulizer System (May 10, 2024)
  • K232523 — Sodium Chloride Inhalation Solution, USP 0.9%, 3% & 7% (April 10, 2024)