Cleared Traditional

K821378 - NON-INVASIVE AUTOMATIC BLOOD PRESSURE

K821378 is an FDA 510(k) clearance for NON-INVASIVE AUTOMATIC BLOOD PRESSURE, manufactured by Narco Scientific. The device is a Class 2 Cardiovascular device with product code DXN cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K821378 · Narco Scientific · Cardiovascular device
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Jul 1982
Decision
59d
Days
Class 2
Risk

K821378 is an FDA 510(k) clearance for the NON-INVASIVE AUTOMATIC BLOOD PRESSURE. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Narco Scientific (Mchenry, US). The FDA issued a Cleared decision on July 8, 1982 after a review of 59 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 Narco Scientific devices

FDA 510(k) Submission Details - K821378

510(k) Number K821378 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 1982
Decision Date July 08, 1982
Days to Decision 59 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
66d faster than avg
Panel avg: 125d · This submission: 59d
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 660
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K821378.
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K820135 · Sybron Corp. · Mar 1982
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K813385 · Conphar, Inc. · Jan 1982