Cleared Traditional

K202171 - Pulmogine Vibrating Mesh Nebulizer

K202171 is an FDA 510(k) clearance for Pulmogine Vibrating Mesh Nebulizer, manufactured by Hcmed Innovations Co., Ltd.. The device is a Class 2 Anesthesiology device with product code CAF cleared through the Traditional 510(k) pathway after a 332-day FDA review.

K202171 · Hcmed Innovations Co., Ltd. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2021
Decision
332d
Days
Class 2
Risk

K202171 is an FDA 510(k) clearance for the Pulmogine Vibrating Mesh Nebulizer. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Hcmed Innovations Co., Ltd. (Taipei City, TW). The FDA issued a Cleared decision on July 1, 2021 after a review of 332 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5630 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Hcmed Innovations Co., Ltd. devices

FDA 510(k) Submission Details - K202171

510(k) Number K202171 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 2020
Decision Date July 01, 2021
Days to Decision 332 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
192d slower than avg
Panel avg: 140d · This submission: 332d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CAF Device Classification - Class 2, Special Controls

Product Code CAF Nebulizer (direct Patient Interface)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5630
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Peers - CAF Nebulizer (direct Patient Interface)

All 196
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K202171.
BreatheSuite MDI V1
K203155 · Breathesuite, Inc. · Sep 2021
Hailie Sensor NF0109
K211233 · Adherium (Nz), Ltd. · Aug 2021
Nebulizer Kit
K192971 · Excellentcare Medical (Huizhou) , Ltd. · Jul 2021
Ultrasonic Mesh Nebulizer
K201397 · Shenzhen Ivankaca Technology Co., Ltd. · Jun 2021
Corrugated tube with mouthpiece accessory
K203400 · Trudell Medical International · Jun 2021
AireHealth NebulizerTM
K201167 · Airehealth, Inc. · Dec 2020