Cleared Traditional

K191239 - Smart Peak Flow Meter

K191239 is an FDA 510(k) clearance for Smart Peak Flow Meter, manufactured by Guangzhou Homesun Medical Technology Co., Ltd.. The device is a Class 2 Anesthesiology device with 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

FDA 510(k) Submission Details - K191239

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.

BZH Device Classification - Class 2, Special Controls

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 51
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