Cleared Traditional

K101972 - SOLARIS REUSABLE AND DISPOSABLE BLOOD P...

K101972 is an FDA 510(k) clearance for SOLARIS REUSABLE AND DISPOSABLE BLOOD P..., manufactured by Solaris Medical Technology, Inc.. The device is a Class 2 Cardiovascular device with product code DXQ cleared through the Traditional 510(k) pathway after a 9-day FDA review.

K101972 · Solaris Medical Technology, Inc. · Cardiovascular device
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Jul 2010
Decision
9d
Days
Class 2
Risk

K101972 is an FDA 510(k) clearance for the SOLARIS REUSABLE AND DISPOSABLE BLOOD PRESSURE CUFFS. Classified as Blood Pressure Cuff (product code DXQ), Class II - Special Controls.

Submitted by Solaris Medical Technology, Inc. (South San Francisco, US). The FDA issued a Cleared decision on July 22, 2010 after a review of 9 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 Solaris Medical Technology, Inc. devices

FDA 510(k) Submission Details - K101972

510(k) Number K101972 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 13, 2010
Decision Date July 22, 2010
Days to Decision 9 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
116d faster than avg
Panel avg: 125d · This submission: 9d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 100
Devices cleared under the same product code (DXQ) and FDA review panel - the closest regulatory comparables to K101972.
SOFT-CUF, CLASSIC-CUF, DURA-CUF, SENSA-CUF
K120125 · Ge Medical Systems Information Technologies, Inc. · Oct 2012
UNIMED DISPOSABLE BLOOD PRESSURE CUFF
K120364 · Unimed Medical Supplies, Inc. · May 2012
UNIMED BLOOD PRESSURE CUFF
K112544 · Unimed Medical Supplies, Inc. · Nov 2011
MEDLINE SINGLE PATIENT USE BLOOD PRESSURE CUFF
K071244 · Medline Industries, Inc. · Mar 2008
WELCH ALLYN FLEXIPORT DISPOSABLE BLOOD PRESSURE CUFF (ONE-PIECE)
K070060 · Welch Allyn, Inc. · Dec 2007
POLYURETHANE BLOOD PRESSURE CUFFS
K041689 · D. E. Hokanson, Inc. · Aug 2004