Cleared Traditional

K930894 - MULTITRAK-PLUS

K930894 is an FDA 510(k) clearance for MULTITRAK-PLUS, manufactured by Zymed Medical Instrumentation. The device is a Class 2 Cardiovascular device with product code DSH cleared through the Traditional 510(k) pathway after a 252-day FDA review.

K930894 · Zymed Medical Instrumentation · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1993
Decision
252d
Days
Class 2
Risk

K930894 is an FDA 510(k) clearance for the MULTITRAK-PLUS. Classified as Recorder, Magnetic Tape, Medical (product code DSH), Class II - Special Controls.

Submitted by Zymed Medical Instrumentation (Camarillo, US). The FDA issued a Cleared decision on November 1, 1993 after a review of 252 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2800 - 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.

FDA 510(k) Submission Details - K930894

510(k) Number K930894 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 1993
Decision Date November 01, 1993
Days to Decision 252 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
127d slower than avg
Panel avg: 125d · This submission: 252d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DSH Device Classification - Class 2, Special Controls

Product Code DSH Recorder, Magnetic Tape, Medical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2800
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 - DSH Recorder, Magnetic Tape, Medical

All 178
Devices cleared under the same product code (DSH) and FDA review panel - the closest regulatory comparables to K930894.
ALTAIR 6100 CASSETTE RECORDER
K942438 · Burdick, Inc. · Aug 1994
SCOLE 300 ECG RECORDER
K923664 · Scole Engineering Co. · Jan 1994
R AND D BATTERIES, INC. PART NUMBERS 5310, 5063 & 5211
K934660 · R & D Batteries, Inc. · Dec 1993
HRV 4000EM
K932929 · All-Tronics Medical Systems · Sep 1993
UNISCAN 24 ECG ROCORDER
K920572 · Uniscan , Ltd. · Apr 1992
GIKTER ECG CASSETTE TAPE RECORDER MODEL XR 300
K921068 · Datrix · Mar 1992
K930894 · MULTITRAK-PLUS
Download PDF Zymed Medical Instrum…