Cleared Traditional

BLOOD PRESSURE SLEEVE W/TUBING (K874233) - FDA 510(k) Clearance

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

K874233 · Devcom, Inc. · Cardiovascular device
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Mar 1988
Decision
159d
Days
Class 2
Risk

K874233 is an FDA 510(k) clearance for the BLOOD PRESSURE SLEEVE W/TUBING. Classified as Blood Pressure Cuff (product code DXQ), Class II - Special Controls.

Submitted by Devcom, Inc. (Paoli, US). The FDA issued a Cleared decision on March 22, 1988 after a review of 159 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Devcom, Inc. devices

Submission Details

510(k) Number K874233 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 1987
Decision Date March 22, 1988
Days to Decision 159 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
34d slower than avg
Panel avg: 125d · This submission: 159d
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 45
Devices cleared under the same product code (DXQ) and FDA review panel - the closest regulatory comparables to K874233.
ADULT,STERILE,DISPOS.,NONIVAS.,BLOOD PRESS. CUFFS
K905147 · Hewlett-Packard Co. · Dec 1990
NEONATAL/STERILE/DISPOS/NONINVAS BLOOD PRESS CUFF
K905101 · Hewlett-Packard Co. · Dec 1990
HEWLETT-PACKARD SERIES OF DISPOSABLE NIBP CUFFS
K901252 · Hewlett-Packard Co. · Jul 1990
POROCOAT SCHATZKER II ACETABULUM
K852193 · Depuy, Inc. · Jul 1985
P.C.A. TOTAL HIP FEMORAL COMPONENT MODIFICATION
K852964 · Howmedica Corp. · Jul 1985
HOMEDICA CEMENTED ACETABULAR COMPONENT 6262
K851565 · Howmedica Corp. · Jul 1985