Cleared Traditional

K954277 - ASTECH PEAK FLOW METER

K954277 is an FDA 510(k) clearance for ASTECH PEAK FLOW METER, manufactured by Center Laboratories, Inc.. The device is a Class 2 Anesthesiology device with product code BZH cleared through the Traditional 510(k) pathway after a 163-day FDA review.

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

FDA 510(k) Submission Details - K954277

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
23d slower than avg
Panel avg: 140d · This submission: 163d
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 47
Devices cleared under the same product code (BZH) and FDA review panel - the closest regulatory comparables to K954277.
AUTOZONE
K952909 · Health Scan, Inc. · Mar 1996
TRUPEAK PEAK FLOW METER
K955234 · Monaghan Medical Corp. · Mar 1996
TRUZONE PEAK FLOW METER
K955262 · Monaghan Medical Corp. · Mar 1996
CARD GUARD
K934795 · Card Guard Scientific Survival , Ltd. · Apr 1995
FLOW SPIROMETER
K934502 · Healthdyne, Inc. · Apr 1994
PEAK FLOW METER
K926307 · Monaghan Medical Corp. · Jul 1993