Cleared Traditional

K911097 - PR4

K911097 is an FDA 510(k) clearance for PR4, manufactured by Mortara Instrument, Inc.. The device is a Class 2 Cardiovascular device with product code DSH cleared through the Traditional 510(k) pathway after a 148-day FDA review.

K911097 · Mortara Instrument, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1991
Decision
148d
Days
Class 2
Risk

K911097 is an FDA 510(k) clearance for the PR4. Classified as Recorder, Magnetic Tape, Medical (product code DSH), Class II - Special Controls.

Submitted by Mortara Instrument, Inc. (Marlboro, US). The FDA issued a Cleared decision on August 7, 1991 after a review of 148 days - within the typical 510(k) review window.

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 - K911097

510(k) Number K911097 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 1991
Decision Date August 07, 1991
Days to Decision 148 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
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: 125d · This submission: 148d
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 176
Devices cleared under the same product code (DSH) and FDA review panel - the closest regulatory comparables to K911097.
GALIX MODEL MA-6R HOLTER REEL-TO-REEL RECORDER
K904176 · Galix Instrumentacion Biomedica · Sep 1991
GALIX MA-6C HOLTER CASSETTE RECORDER
K904177 · Galix Instrumentacion Biomedica · Sep 1991
MR-5200 FULL DISCLOSURE SYSTEM
K911257 · Mennen Medical, Inc. · Aug 1991
MULTICHANNEL RECORDING SYSTEM
K912427 · Bionique · Jul 1991
ADVANCED ISCHEMICA RECORDERS MODEL 2000 CASSETTE
K902766 · Advanced Ischemia Recorders, Inc. · Mar 1991
ROZINN 151
K903331 · Rozinn Electronics, Inc. · Oct 1990
K911097 · PR4
Download PDF Mortara Instrument, I…