Cleared Traditional

SENSA-CUFF, MODELS INFANT, CHILD, ADULT (K022482) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K022482 · Ge Medical Systems Information Technologies · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Aug 2002
Decision
15d
Days
Class 2
Risk

K022482 is an FDA 510(k) clearance for the SENSA-CUFF, MODELS INFANT, CHILD, ADULT. Classified as Blood Pressure Cuff (product code DXQ), Class II - Special Controls.

Submitted by Ge Medical Systems Information Technologies (Tampa, US). The FDA issued a Cleared decision on August 13, 2002 after a review of 15 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1120 - 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 Ge Medical Systems Information Technologies devices

Submission Details

510(k) Number K022482 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 2002
Decision Date August 13, 2002
Days to Decision 15 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
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. Third-party reviewed.

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 Consultant

Underwriters Laboratories, Inc.
JEFF D RONGERO

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - DXQ Blood Pressure Cuff

All 59
Devices cleared under the same product code (DXQ) and FDA review panel - the closest regulatory comparables to K022482.
FLEXIPORT ECOCUFF
K122058 · Welch Allyn, Inc. · Nov 2012
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
WELCH ALLYN DURASHOCK BLOOD PRESSURE SYSTEM
K012455 · Welch Allyn, Inc. · Aug 2001
HAND ANEROID SPHYGMOMANOMETER
K940493 · Welch Allyn, Inc. · Jul 1994
ADULT,STERILE,DISPOS.,NONIVAS.,BLOOD PRESS. CUFFS
K905147 · Hewlett-Packard Co. · Dec 1990