Cleared Traditional

K820539 - RELIEVED REINFORCED CUP

K820539 is the FDA 510(k) clearance for RELIEVED REINFORCED CUP by Biomet, Inc.. It is a Class 2 Cardiovascular device (product code DXQ) cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K820539 · Biomet, Inc. · Cardiovascular device

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Mar 1982

Decision

13d

Days

Class 2

Risk

K820539 is an FDA 510(k) clearance for the RELIEVED REINFORCED CUP. Classified as Blood Pressure Cuff (product code DXQ), Class II - Special Controls.

Submitted by Biomet, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 15, 1982 after a review of 13 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1120 - 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 Biomet, Inc. devices

Submission Details

510(k) Number	K820539 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 02, 1982
Decision Date	March 15, 1982
Days to Decision	13 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

112d faster than avg

Panel avg: 125d · This submission: 13d

Pathway characteristics

Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code	DXQ Blood Pressure Cuff
Device Class	Class 2 - Special Controls
CFR Regulation	21 CFR 870.1120
Definition	A Blood Pressure Cuff Is A Device That Has An Inflatable Bladder In An Elastic Sleeve (cuff) With A Mechanism For Inflating The Bladder. The Cuff Is Used To Determine A Subject's Blood Pressure.

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 - DXQ Blood Pressure Cuff

All 73

Devices cleared under the same product code (DXQ) and FDA review panel - the closest regulatory comparables to K820539.

FREEMAN ACETABULAR CUP

K823843 · Depuy, Inc. · Mar 1983

AUFRANC-TURNER ATS METAL BACKED ACETABU

K830097 · Howmedica Corp. · Jan 1983

ONE HAND ANEROID SPHYGMOMANOMETER

K821232 · Abco Dealers, Inc. · May 1982

CONPHAR PALM ANEROID SPHYGMOMANOMETER

K813302 · Conphar, Inc. · Jan 1982

CONPHAR, WALL ANEROID SPHYGMOMANOMETER

K813303 · Conphar, Inc. · Jan 1982

THIGH CUFF: X-LARGE CUFF

K813323 · Abco Dealers, Inc. · Dec 1981

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K820539

Biomet, Inc.

Mchenry, IL · US

Regulatory profile

442 submissions 420 cleared

95% clearance rate · Active in Cardiovascular

Data Intelligence Layer

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Sourced from FDA 510(k) public files . Updated monthly.

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