Cleared Traditional

K791637 - TENS-O-TEST

K791637 is the FDA 510(k) clearance for TENS-O-TEST by Curomatic, Inc.. It is a Class 2 Cardiovascular device (product code DXN) cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K791637 · Curomatic, Inc. · Cardiovascular device
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Sep 1979
Decision
22d
Days
Class 2
Risk

K791637 is an FDA 510(k) clearance for the TENS-O-TEST. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Curomatic, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 12, 1979 after a review of 22 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 Curomatic, Inc. devices

Submission Details

510(k) Number K791637 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 1979
Decision Date September 12, 1979
Days to Decision 22 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
103d faster than avg
Panel avg: 125d · This submission: 22d
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 547
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K791637.
NON-INVASIVE, BLOOD PRESSURE MONITOR
K801657 · Biochem International, Inc. · Aug 1980
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MODEL 1978 PRESSUROMETER III AMBULATORY
K792075 · Del Mar Avionics · Dec 1979
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K791054 · C.R. Bard, Inc. · Jul 1979
QUICK-CHECK
K790277 · United States Surgical, A Division of Tyco Healthc · Mar 1979
AUTOMATIC BLOOD PRESSURE DEVICE
K781517 · Welch Allyn, Inc. · Jan 1979