Cleared Traditional

K781053 - DINAMAP MODEL 846

K781053 is the FDA 510(k) clearance for DINAMAP MODEL 846 by Applied Medical Research. It is a Class 2 Cardiovascular device (product code DSK) cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K781053 · Applied Medical Research · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1978
Decision
77d
Days
Class 2
Risk

K781053 is an FDA 510(k) clearance for the DINAMAP MODEL 846. Classified as Computer, Blood-pressure (product code DSK), Class II - Special Controls.

Submitted by Applied Medical Research (Mchenry, US). The FDA issued a Cleared decision on September 7, 1978 after a review of 77 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1110 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Applied Medical Research devices

Submission Details

510(k) Number K781053 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 1978
Decision Date September 07, 1978
Days to Decision 77 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 125d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DSK Computer, Blood-pressure
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1110
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 - DSK Computer, Blood-pressure

All 35
Devices cleared under the same product code (DSK) and FDA review panel - the closest regulatory comparables to K781053.
PRESSURE MONITOR, MODEL 1131B
K801110 · American Optical Corp. · May 1980
MODEL 1981 PRESSUROMETER DATA ANALYSIS
K792077 · Del Mar Avionics · Dec 1979
MONITOR, PRESSURVEIL
K790135 · Concept, Inc. · Feb 1979
GOULD-STATHAM SP1405 PRESSURE MONITOR
K780798 · Gould, Inc. · Jun 1978
MONITOR, CARDIAC, W/BLOOD PRESS.&TEMP
K772334 · Telectronics, Inc. · Feb 1978
CARDIAC OUTPUT MODULE-78231C
K772234 · Hewlett-Packard Co. · Jan 1978