Portable mesh nebulizer (JM821)— 510(k) K244035

Name: FDA 510(k) clearance K244035
Creator: U.S. Food and Drug Administration
Published: 2025-09-19

Substantially Equivalent

Shenzhen Jermei Medical Device Technology Co., Ltd.

FDA 510(k) clearance K244035 for Portable mesh nebulizer (JM821), Substantially Equivalent on 2025-09-19. Applicant: Shenzhen Jermei Medical Device Technology Co., Ltd.. Device class: 2.

Clearance details

Applicant: Shenzhen Jermei Medical Device Technology Co., Ltd.
Product code: Code CAF
Device class: Class 2
Regulation: 21 CFR 868.5630
Advisory panel: Anesthesiology
Date received: 2024-12-30
Decision date: 2025-09-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, CN

Download summary PDF View on FDA.gov ↗

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K251572 — eRapid with eTrack System2025-12-19
K251659 — Mesh Nebulizer (H6)2025-11-14
K243468 — Compressor Nebulizer (4 models)2025-07-02
K250022 — HeroTracker Sense2025-06-30

Adverse events under product code CAF

product code CAF

Death: 22
Injury: 125
Malfunction: 613
Other: 11
Total: 771

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.