Cleared Traditional

K771981 - MINIMAP MODEL 810

K771981 is the FDA 510(k) clearance for MINIMAP MODEL 810 by Applied Medical Research. It is a Class 2 Cardiovascular device (product code DSK) cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K771981 · Applied Medical Research · Cardiovascular device
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Jan 1978
Decision
98d
Days
Class 2
Risk

K771981 is an FDA 510(k) clearance for the MINIMAP MODEL 810. Classified as Computer, Blood-pressure (product code DSK), Class II - Special Controls.

Submitted by Applied Medical Research (Walker, US). The FDA issued a Cleared decision on January 24, 1978 after a review of 98 days - within the typical 510(k) review window.

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: 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 Applied Medical Research devices

Submission Details

510(k) Number K771981 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 1977
Decision Date January 24, 1978
Days to Decision 98 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
27d faster than avg
Panel avg: 125d · This submission: 98d
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 K771981.
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
CARDIAC OUTPUT COMPUTER MODEL 701
K771977 · Instrumentation Laboratory CO · Jan 1978