Cleared Traditional

K170281 - MSA100BT Peak Flow Meter

K170281 is an FDA 510(k) clearance for MSA100BT Peak Flow Meter, manufactured by Beijing M&B Electronic Instruments Co., Ltd.. The device is a Class 2 Anesthesiology device with product code BZH cleared through the Traditional 510(k) pathway after a 249-day FDA review.

K170281 · Beijing M&B Electronic Instruments Co., Ltd. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2017
Decision
249d
Days
Class 2
Risk

K170281 is an FDA 510(k) clearance for the MSA100BT Peak Flow Meter. Classified as Meter, Peak Flow, Spirometry (product code BZH), Class II - Special Controls.

Submitted by Beijing M&B Electronic Instruments Co., Ltd. (Beijing, CN). The FDA issued a Cleared decision on October 6, 2017 after a review of 249 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.

FDA 510(k) Submission Details - K170281

510(k) Number K170281 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 30, 2017
Decision Date October 06, 2017
Days to Decision 249 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
109d slower than avg
Panel avg: 140d · This submission: 249d
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

Guangzhou Osmunda Medical Device Technical Services Co., Ltd.
Mike Gu

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 67
Devices cleared under the same product code (BZH) and FDA review panel - the closest regulatory comparables to K170281.
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
Wing Smart FEVI and Peak Flow Meter
K152276 · Sparo, Inc. · Jun 2016
MSA100 PEAK FLOW METER
K133975 · Beijing M&B Electronic Instruments Co., Ltd. · Oct 2014
STRIVE DUAL ZONE PEAK FLOW METER
K123945 · Monaghan Medical Corp. · Apr 2013