Cleared Traditional

K883977 - SURGI-CUF STERILE/NON-STERILE DISPOSABLE

K883977 is the FDA 510(k) clearance for SURGI-CUF STERILE/NON-STERILE DISPOSABLE by Ethox Corp.. It is a Class 2 Cardiovascular device (product code DXQ) cleared through the Traditional 510(k) pathway after a 143-day FDA review.

K883977 · Ethox Corp. · Cardiovascular device
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Feb 1989
Decision
143d
Days
Class 2
Risk

K883977 is an FDA 510(k) clearance for the SURGI-CUF STERILE/NON-STERILE DISPOSABLE. Classified as Blood Pressure Cuff (product code DXQ), Class II - Special Controls.

Submitted by Ethox Corp. (Buffalo, US). The FDA issued a Cleared decision on February 10, 1989 after a review of 143 days - within the typical 510(k) review window.

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 Ethox Corp. devices

Submission Details

510(k) Number K883977 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 1988
Decision Date February 10, 1989
Days to Decision 143 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
18d slower than avg
Panel avg: 125d · This submission: 143d
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 74
Devices cleared under the same product code (DXQ) and FDA review panel - the closest regulatory comparables to K883977.
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
C-FLO SUCTION TUBE
K882121 · Concept, Inc. · Jun 1988
SCHURMAN/CARTER II HIP PROSTHESIS, POROUS COATED
K874939 · Kirschner Medical Corp. · Feb 1988
POROCOAT SCHATZKER II ACETABULUM
K852193 · Depuy, Inc. · Jul 1985