Cleared Traditional

K941162 - HYPERGRAPH

K941162 is an FDA 510(k) clearance for HYPERGRAPH, manufactured by Dermed Diagnostics, Inc.. The device is a Class 2 Cardiovascular device with product code DSB cleared through the Traditional 510(k) pathway after a 279-day FDA review.

K941162 · Dermed Diagnostics, Inc. · Cardiovascular device
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Dec 1994
Decision
279d
Days
Class 2
Risk

K941162 is an FDA 510(k) clearance for the HYPERGRAPH. Classified as Plethysmograph, Impedance (product code DSB), Class II - Special Controls.

Submitted by Dermed Diagnostics, Inc. (Wheaton, US). The FDA issued a Cleared decision on December 15, 1994 after a review of 279 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2770 - the FDA cardiovascular device oversight 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 Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Dermed Diagnostics, Inc. devices

FDA 510(k) Submission Details - K941162

510(k) Number K941162 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 1994
Decision Date December 15, 1994
Days to Decision 279 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
154d slower than avg
Panel avg: 125d · This submission: 279d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DSB Device Classification - Class 2, Special Controls

Product Code DSB Plethysmograph, Impedance
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2770
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - DSB Plethysmograph, Impedance

All 57
Devices cleared under the same product code (DSB) and FDA review panel - the closest regulatory comparables to K941162.
PERCUPUMP II WITH EDA
K961845 · E-Z-Em, Inc. · Jan 1997
BIOZ SYSTEM
K963183 · Cardiodynamics International Corp. · Nov 1996
NICAS 2001 NONINVASIVE CARDIO-RESPIRATORY SYSTEM
K942227 · C.L. Mcintosh & Assoc., Inc. · Jun 1996
PROCORD MD3500 VASCULAR DIAGNOSTIC SYSTEM
K896034 · D. E. Hokanson, Inc. · Jan 1990
DANNINGER TRIMCHECK(TM) PORTABLE & DESK TOP MODELS
K881841 · Buckman Co., Inc. · Dec 1988
BIODYNAMICS MODEL 200 BODY COMPOSITION ANALYZER
K884033 · Biodynamics Corp. · Nov 1988