Cleared Traditional

K880351 - VITAL SYSTEM

K880351 is an FDA 510(k) clearance for VITAL SYSTEM, manufactured by Pace Tech, Inc.. The device is a Class 2 Cardiovascular device with product code DXN cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K880351 · Pace Tech, Inc. · Cardiovascular device
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Mar 1988
Decision
56d
Days
Class 2
Risk

K880351 is an FDA 510(k) clearance for the VITAL SYSTEM. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Pace Tech, Inc. (Clearwater, US). The FDA issued a Cleared decision on March 22, 1988 after a review of 56 days - a notably fast clearance 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: 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 Pace Tech, Inc. devices

FDA 510(k) Submission Details - K880351

510(k) Number K880351 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 26, 1988
Decision Date March 22, 1988
Days to Decision 56 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
69d faster than avg
Panel avg: 125d · This submission: 56d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXN Device Classification - Class 2, Special Controls

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 648
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K880351.
MODEL 404 ADULT HEART RATE/BLOOD PRESSURE MONITOR
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PYTHON AMBULATORY BLOOD PRESSURE MONITORING SYSTEM
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OHMEDA 2350 FINAPRES(R) BLOOD PRESSURE MONITOR
K880572 · Ohmeda Medical · May 1988
NON-INVASIVE BLOOD PRESSURE MODULE
K875265 · Ppg Industries, Inc. · Feb 1988
DINAMAP VITAL SIGNS MONITOR, MODEL 8100T
K874378 · Critikon Company, LLC · Dec 1987
TAKEDA MEDICAL DIGITAL SPHYGMOMANOMETER/ UA-741
K872629 · A&D Engineering, Inc. · Sep 1987