Cleared Traditional

K790470 - THE GUARDIAN SPHYGMOMANOMETER

K790470 is the FDA 510(k) clearance for THE GUARDIAN SPHYGMOMANOMETER by World Book Encyclopedia, Inc.. It is a Class 2 Cardiovascular device (product code DXN) cleared through the Traditional 510(k) pathway after a 11-day FDA review.

K790470 · World Book Encyclopedia, Inc. · Cardiovascular device
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Mar 1979
Decision
11d
Days
Class 2
Risk

K790470 is an FDA 510(k) clearance for the THE GUARDIAN SPHYGMOMANOMETER. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by World Book Encyclopedia, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 16, 1979 after a review of 11 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 World Book Encyclopedia, Inc. devices

Submission Details

510(k) Number K790470 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 1979
Decision Date March 16, 1979
Days to Decision 11 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
114d faster than avg
Panel avg: 125d · This submission: 11d
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 K790470.
MODEL 1978 PRESSUROMETER III AMBULATORY
K792075 · Del Mar Avionics · Dec 1979
HYPER CHEC, SPHYGMOMANOMETER ELECTRONIC
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
PRESSURE INFUSION CUFF
K781556 · Abbott Laboratories · Oct 1978
TREND II ANEROID
K780598 · Abco Dealers, Inc. · Jun 1978