Cleared Traditional

K821095 - SPHYGURITE

K821095 is an FDA 510(k) clearance for SPHYGURITE, manufactured by Associated Medical Devices, Inc.. The device is a Class 2 Cardiovascular device with product code DXQ cleared through the Traditional 510(k) pathway after a 52-day FDA review.

K821095 · Associated Medical Devices, Inc. · Cardiovascular device
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Jun 1982
Decision
52d
Days
Class 2
Risk

K821095 is an FDA 510(k) clearance for the SPHYGURITE. Classified as Blood Pressure Cuff (product code DXQ), Class II - Special Controls.

Submitted by Associated Medical Devices, Inc. (Walker, US). The FDA issued a Cleared decision on June 10, 1982 after a review of 52 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 Associated Medical Devices, Inc. devices

FDA 510(k) Submission Details - K821095

510(k) Number K821095 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 19, 1982
Decision Date June 10, 1982
Days to Decision 52 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 125d · This submission: 52d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXQ Device Classification - Class 2, Special Controls

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 149
Devices cleared under the same product code (DXQ) and FDA review panel - the closest regulatory comparables to K821095.
METAL-BACKED ACETABULAR CUP
K831479 · Dow Corning Corp. Healthcare Industries Materials · Jun 1983
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
RELIEVED REINFORCED CUP
K820539 · Biomet, Inc. · Mar 1982
CONPHAR PALM ANEROID SPHYGMOMANOMETER
K813302 · Conphar, Inc. · Jan 1982