Cleared Traditional

K982995 - ACCUTRAX, MODEL EPF840

K982995 is an FDA 510(k) clearance for ACCUTRAX, manufactured by Korr Medical Technologies, Inc.. The device is a Class 2 Anesthesiology device with product code BZH cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K982995 · Korr Medical Technologies, Inc. · Anesthesiology device
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Dec 1998
Decision
99d
Days
Class 2
Risk

K982995 is an FDA 510(k) clearance for the ACCUTRAX, MODEL EPF840. Classified as Meter, Peak Flow, Spirometry (product code BZH), Class II - Special Controls.

Submitted by Korr Medical Technologies, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on December 4, 1998 after a review of 99 days - within the typical 510(k) review window.

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 Korr Medical Technologies, Inc. devices

FDA 510(k) Submission Details - K982995

510(k) Number K982995 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 1998
Decision Date December 04, 1998
Days to Decision 99 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 140d · This submission: 99d
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 37
Devices cleared under the same product code (BZH) and FDA review panel - the closest regulatory comparables to K982995.
ONEFLOW
K980951 · Sti Medical · Feb 2000
MODIFICATION TO TRUZONE PEAK FLOW METER
K991212 · Monaghan Medical Corp. · Jul 1999
AIRZONE PEAK FLOWMETER
K982334 · Clement Clarke Intl., Ltd. · Jan 1999
AIRWATCH II ZONELESS
K982675 · Enact Health Management Systems · Oct 1998
AIRWATCH II ZONE
K982676 · Enact Health Management Systems · Oct 1998
WHISTLE WATCH
K980550 · Harwill Medical (Pty) , Ltd. · Aug 1998