Cleared Traditional

K810179 - DUAL TRACE PATIENT MONITOR 116

K810179 is an FDA 510(k) clearance for DUAL TRACE PATIENT MONITOR 116, manufactured by Honeywell, Inc.. The device is a Class 2 Cardiovascular device with product code DSK cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K810179 · Honeywell, Inc. · Cardiovascular device
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Feb 1981
Decision
34d
Days
Class 2
Risk

K810179 is an FDA 510(k) clearance for the DUAL TRACE PATIENT MONITOR 116,118,120. Classified as Computer, Blood-pressure (product code DSK), Class II - Special Controls.

Submitted by Honeywell, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 25, 1981 after a review of 34 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 Honeywell, Inc. devices

FDA 510(k) Submission Details - K810179

510(k) Number K810179 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 1981
Decision Date February 25, 1981
Days to Decision 34 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
91d faster than avg
Panel avg: 125d · This submission: 34d
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 35
Devices cleared under the same product code (DSK) and FDA review panel - the closest regulatory comparables to K810179.
PERIPHERAL PULSE FUNCTION BLOCKS
K810171 · Honeywell, Inc. · Feb 1981
PRESSURE FUNCTION BLOCKS
K810172 · Honeywell, Inc. · Feb 1981
PATIENT MONITOR CM111, 112
K810178 · Honeywell, Inc. · Feb 1981
AMP PORTABLE PATIENT PRESSURE MONITOR
K802600 · American Medical Products, Inc. · Nov 1980
PRESSURE MONITOR, MODEL 1131B
K801110 · American Optical Corp. · May 1980
MODEL 1981 PRESSUROMETER DATA ANALYSIS
K792077 · Del Mar Avionics · Dec 1979