Cleared Traditional

K771981 - MINIMAP MODEL 810

K771981 is an FDA 510(k) clearance for MINIMAP MODEL 810, manufactured by Applied Medical Research. The device is a Class 2 Cardiovascular device with 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

FDA 510(k) Submission Details - K771981

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
Combination Product No
PCCP Authorized No
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.

DSK Device Classification - Class 2, Special Controls

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 53
Devices cleared under the same product code (DSK) and FDA review panel - the closest regulatory comparables to K771981.
DINAMAP MODEL 848
K781064 · Applied Medical Research · Sep 1978
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
DINAMAP MODEL 825A
K771772 · Applied Medical Research · Oct 1977