Cleared Traditional

K852978 - COMFORT - CUF

K852978 is the FDA 510(k) clearance for COMFORT - CUF by Dynasty Instruments, Ltd.. It is a Class 2 Cardiovascular device (product code DXN) cleared through the Traditional 510(k) pathway after a 183-day FDA review.

K852978 · Dynasty Instruments, Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1986
Decision
183d
Days
Class 2
Risk

K852978 is an FDA 510(k) clearance for the COMFORT - CUF. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Dynasty Instruments, Ltd. (Indialantic, US). The FDA issued a Cleared decision on January 14, 1986 after a review of 183 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1130 - 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 Dynasty Instruments, Ltd. devices

Submission Details

510(k) Number K852978 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 1985
Decision Date January 14, 1986
Days to Decision 183 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
58d slower than avg
Panel avg: 125d · This submission: 183d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DXN System, Measurement, Blood-pressure, Non-invasive
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1130
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 - DXN System, Measurement, Blood-pressure, Non-invasive

All 537
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K852978.
OSCILLOMATE NEONATAL BLOOD PRESS. MONIT.-MODEL 901
K860196 · Cas Medical Systems, Inc. · May 1986
MPV-7201 NON-INVASIVE BLOOD PRESSURE MONITOR
K854370 · Nihon Kohden America, Inc. · Apr 1986
WELCH ALLYN MODEL 40000 SPHYG W/ 40030-35 BLAD & C
K852574 · Welch Allyn, Inc. · Mar 1986
MODEL 9300 TREND ANALYZING BIO-MONITOR SYS
K844252 · Medtronic Vascular · Jun 1985
ACCU-TRAC
K843055 · Olympic Medical Corp. · May 1985
BLOOD-PRESSURE ECG TRANSMITTER
K844310 · Instromedix, Inc. · Apr 1985