Cleared Traditional

K811980 - ELECTRONIC BLOOD PRESSURE TRANSDUCER MAN

K811980 is the FDA 510(k) clearance for ELECTRONIC BLOOD PRESSURE TRANSDUCER MAN by H.R. Biomedical, Ltd.. It is a Class 2 Cardiovascular device (product code DRS) cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K811980 · H.R. Biomedical, Ltd. · Cardiovascular device
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Jul 1981
Decision
15d
Days
Class 2
Risk

K811980 is an FDA 510(k) clearance for the ELECTRONIC BLOOD PRESSURE TRANSDUCER MAN. Classified as Transducer, Blood-pressure, Extravascular (product code DRS), Class II - Special Controls.

Submitted by H.R. Biomedical, Ltd. (Mchenry, US). The FDA issued a Cleared decision on July 28, 1981 after a review of 15 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2850 - 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 H.R. Biomedical, Ltd. devices

Submission Details

510(k) Number K811980 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 13, 1981
Decision Date July 28, 1981
Days to Decision 15 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
110d faster than avg
Panel avg: 125d · This submission: 15d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DRS Transducer, Blood-pressure, Extravascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2850
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 - DRS Transducer, Blood-pressure, Extravascular

All 85
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