Cleared Traditional

K954277 - ASTECH PEAK FLOW METER (FDA 510(k) Clearance)

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

K954277 · Center Laboratories, Inc. · Anesthesiology device
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Feb 1996
Decision
163d
Days
Class 2
Risk

K954277 is an FDA 510(k) clearance for the ASTECH PEAK FLOW METER. Classified as Meter, Peak Flow, Spirometry (product code BZH), Class II - Special Controls.

Submitted by Center Laboratories, Inc. (Port Washington, US). The FDA issued a Cleared decision on February 21, 1996 after a review of 163 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 Center Laboratories, Inc. devices

Submission Details

510(k) Number K954277 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 1995
Decision Date February 21, 1996
Days to Decision 163 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
24d slower than avg
Panel avg: 139d · This submission: 163d
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 K954277.
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