Cleared Traditional

K253180 - Microlife Digital Peak Flow Meter

K253180 is an FDA 510(k) clearance for Microlife Digital Peak Flow Meter, manufactured by Microlife Corporation. The device is a Class 2 Anesthesiology device with product code BZH cleared through the Traditional 510(k) pathway after a 270-day FDA review.

K253180 · Microlife Corporation · Anesthesiology device
Download Printable Device Report (PDF)
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Jun 2026
Decision
270d
Days
Class 2
Risk

K253180 is an FDA 510(k) clearance for the Microlife Digital Peak Flow Meter, Model PF200B (PF200B). Classified as Meter, Peak Flow, Spirometry (product code BZH), Class II - Special Controls.

Submitted by Microlife Corporation (Taipei, TW). The FDA issued a Cleared decision on June 23, 2026 after a review of 270 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 Microlife Corporation devices

FDA 510(k) Submission Details - K253180

510(k) Number K253180 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 2025
Decision Date June 23, 2026
Days to Decision 270 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
130d slower than avg
Panel avg: 140d · This submission: 270d
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 Peers - BZH Meter, Peak Flow, Spirometry

All 27
Devices cleared under the same product code (BZH) and FDA review panel - the closest regulatory comparables to K253180.
Peak Flow Meter (PF-10(BR-PEF231))
K252802 · Shenzhen Bi-Rich Medical Devices Co., Ltd. · May 2026
Peak Flow Meter
K241338 · Chongqing Moffy Innovation Technology Co., Ltd. · Dec 2024
Aluna 2
K232588 · Knox Medical Diagnostics · Nov 2024
Electronic Peak Flow Meter
K230423 · Taian Dalu Medical Instrument Co., Ltd. · Feb 2024
TD-7301 Peak Flow meter
K222810 · Gostar Co., Ltd. · Dec 2023
Peak flow meter
K203196 · Shanghai Sonmol Medical Equipment Co., Ltd. · May 2021