Cleared Traditional

MODEL IM1000 INTEGRATED MONITOR (K810731) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K810731 · Gould, Inc. · Cardiovascular device
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Mar 1981
Decision
10d
Days
Class 2
Risk

K810731 is an FDA 510(k) clearance for the MODEL IM1000 INTEGRATED MONITOR. Classified as Computer, Diagnostic, Programmable (product code DQK), Class II - Special Controls.

Submitted by Gould, Inc. (Walker, US). The FDA issued a Cleared decision on March 27, 1981 after a review of 10 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1425 - 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 Gould, Inc. devices

Submission Details

510(k) Number K810731 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 1981
Decision Date March 27, 1981
Days to Decision 10 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
115d faster than avg
Panel avg: 125d · This submission: 10d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DQK Computer, Diagnostic, Programmable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1425
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 - DQK Computer, Diagnostic, Programmable

All 184
Devices cleared under the same product code (DQK) and FDA review panel - the closest regulatory comparables to K810731.
QUINTON Q.CATH
K862740 · Quinton, Inc. · Oct 1986
SIRECUST 425, RESPECTIVELY SIRECUST 430
K851637 · Siemens Medical Solutions USA, Inc. · Jul 1985
Q3000
K834567 · Quinton, Inc. · Apr 1984
PDS CARDIAC CALC. SOFTW. PROGR. #A3604AE
K810750 · General Electric Co. · Mar 1981
QUINTON STATUS 1000
K782072 · Quinton, Inc. · Feb 1979
MODEL 5621A INTERFACE
K780768 · Hewlett-Packard Co. · May 1978