Cleared Traditional

K191239 - Smart Peak Flow Meter

K191239 is the FDA 510(k) clearance for Smart Peak Flow Meter by Guangzhou Homesun Medical Technology Co., Ltd.. It is a Class 2 Anesthesiology device (product code BZH) cleared through the Traditional 510(k) pathway after a 212-day FDA review.

K191239 · Guangzhou Homesun Medical Technology Co., Ltd. · Anesthesiology device
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Dec 2019
Decision
212d
Days
Class 2
Risk

K191239 is an FDA 510(k) clearance for the Smart Peak Flow Meter. Classified as Meter, Peak Flow, Spirometry (product code BZH), Class II - Special Controls.

Submitted by Guangzhou Homesun Medical Technology Co., Ltd. (Guangzhou, CN). The FDA issued a Cleared decision on December 6, 2019 after a review of 212 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1860 - 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. Standard predicate reliance. 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 Guangzhou Homesun Medical Technology Co., Ltd. devices

Submission Details

510(k) Number K191239 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 2019
Decision Date December 06, 2019
Days to Decision 212 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
72d slower than avg
Panel avg: 140d · This submission: 212d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code BZH Meter, Peak Flow, Spirometry
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1860
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 Consultant

Feiying Drug & Medical Consulting Technical Service Group
Tracy Che

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - BZH Meter, Peak Flow, Spirometry

All 25
Devices cleared under the same product code (BZH) and FDA review panel - the closest regulatory comparables to K191239.
Peak flow meter
K203196 · Shanghai Sonmol Medical Equipment Co., Ltd. · May 2021
Safey Peak Flow Meter
K200832 · Safey Medical Devices Pvt, Ltd. · Jul 2020
Aluna
K193311 · Knox Medical Diagnostics, Inc. · Mar 2020
Peak.me
K180487 · Breathe Me, Ltd. · Oct 2018
Smart One
K181666 · Mir Medical International Research · Aug 2018
Besmed Peak Flow Meter
K172804 · Besmed Health Business Corp · Jan 2018