Cleared Traditional

DISPOSABLE PENILE BLOOD PRESSURE CUFFS (K932851) - FDA 510(k) Clearance

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

K932851 · D. E. Hokanson, Inc. · Gastroenterology & Urology device
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Nov 1993
Decision
158d
Days
Class 2
Risk

K932851 is an FDA 510(k) clearance for the DISPOSABLE PENILE BLOOD PRESSURE CUFFS. Classified as Blood Pressure Cuff (product code DXQ), Class II - Special Controls.

Submitted by D. E. Hokanson, Inc. (Bellevue, US). The FDA issued a Cleared decision on November 15, 1993 after a review of 158 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 870.1120 - the FDA gastroenterology and urology device 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 Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all D. E. Hokanson, Inc. devices

Submission Details

510(k) Number K932851 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 1993
Decision Date November 15, 1993
Days to Decision 158 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
28d slower than avg
Panel avg: 130d · This submission: 158d
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 Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - DXQ Blood Pressure Cuff

All 44
Devices cleared under the same product code (DXQ) and FDA review panel - the closest regulatory comparables to K932851.
Accutension Smartphone Auscultatory Blood
K180335 · Shanghai Hulu Devices Co., Ltd. · Mar 2018
Medline Singe Patient Use Blood Pressure Cuff
K161035 · Medline Industries, Inc. · Jun 2016
MEDLINE SINGLE PATIENT USE BLOOD PRESSURE CUFF
K071244 · Medline Industries, Inc. · Mar 2008
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