Cleared Traditional

K230423 - Electronic Peak Flow Meter

K230423 is an FDA 510(k) clearance for Electronic Peak Flow Meter, manufactured by Taian Dalu Medical Instrument Co., Ltd.. The device is a Class 2 Anesthesiology device with product code BZH cleared through the Traditional 510(k) pathway after a 371-day FDA review.

K230423 · Taian Dalu Medical Instrument Co., Ltd. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2024
Decision
371d
Days
Class 2
Risk

K230423 is an FDA 510(k) clearance for the Electronic Peak Flow Meter. Classified as Meter, Peak Flow, Spirometry (product code BZH), Class II - Special Controls.

Submitted by Taian Dalu Medical Instrument Co., Ltd. (Taian City, CN). The FDA issued a Cleared decision on February 23, 2024 after a review of 371 days - an unusually long review period, suggesting complex equivalence evaluation.

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. 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 Taian Dalu Medical Instrument Co., Ltd. devices

FDA 510(k) Submission Details - K230423

510(k) Number K230423 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 17, 2023
Decision Date February 23, 2024
Days to Decision 371 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
231d slower than avg
Panel avg: 140d · This submission: 371d
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 26
Devices cleared under the same product code (BZH) and FDA review panel - the closest regulatory comparables to K230423.
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
TD-7301 Peak Flow meter
K222810 · Gostar Co., Ltd. · Dec 2023
Peak flow meter
K203196 · Shanghai Sonmol Medical Equipment Co., Ltd. · May 2021
Safey Peak Flow Meter
K200832 · Safey Medical Devices Pvt, Ltd. · Jul 2020