Cleared Traditional

K030586 - MICROPEAK (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K030586 · Micro Direct, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2003
Decision
184d
Days
Class 2
Risk

K030586 is an FDA 510(k) clearance for the MICROPEAK. Classified as Meter, Peak Flow, Spirometry (product code BZH), Class II - Special Controls.

Submitted by Micro Direct, Inc. (Lewiston, US). The FDA issued a Cleared decision on August 27, 2003 after a review of 184 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 Micro Direct, Inc. devices

Submission Details

510(k) Number K030586 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 2003
Decision Date August 27, 2003
Days to Decision 184 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
45d slower than avg
Panel avg: 139d · This submission: 184d
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 Peers - BZH Meter, Peak Flow, Spirometry

All 78
Devices cleared under the same product code (BZH) and FDA review panel - the closest regulatory comparables to K030586.
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