Cleared Traditional

K801657 - NON-INVASIVE, BLOOD PRESSURE MONITOR

K801657 is an FDA 510(k) clearance for NON-INVASIVE, manufactured by Biochem International, Inc.. The device is a Class 2 Cardiovascular device with product code DXN cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K801657 · Biochem International, Inc. · Cardiovascular device
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Aug 1980
Decision
30d
Days
Class 2
Risk

K801657 is an FDA 510(k) clearance for the NON-INVASIVE, BLOOD PRESSURE MONITOR. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Biochem International, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 20, 1980 after a review of 30 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 Biochem International, Inc. devices

FDA 510(k) Submission Details - K801657

510(k) Number K801657 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 1980
Decision Date August 20, 1980
Days to Decision 30 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
95d faster than avg
Panel avg: 125d · This submission: 30d
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 649
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K801657.
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MODEL 1978 PRESSUROMETER III AMBULATORY
K792075 · Del Mar Avionics · Dec 1979