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510(k) K212395

Nebulizer by Shenzhen Homed Medical Device Co., Ltd. — Product Code CAF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 25, 2022
Date Received
August 2, 2021
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 Shenzhen Homed Medical Device Co., Ltd.

  • K252616 — Portable oxygen concentrator (JLO-190P) (December 22, 2025)
  • K170886 — HOMED Mesh Nebulizer (June 21, 2018)
  • K161586 — The JLN-23XX Series Piston Compress Nebulizer (with models JLN-2300AS, JLN-2301A (September 6, 2017)

Other clearances for product code CAF

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  • 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)