Cleared Traditional

K925744 - TEMPA-KUFF SINGLE PAT PRE-GAGED BALANCED DISP CUFF

K925744 is an FDA 510(k) clearance for TEMPA-KUFF SINGLE PAT PRE-GAGED BALANCE..., manufactured by Pymah Corp.. The device is a Class 2 Cardiovascular device with product code DXQ cleared through the Traditional 510(k) pathway after a 259-day FDA review.

K925744 · Pymah Corp. · Cardiovascular device
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Jul 1993
Decision
259d
Days
Class 2
Risk

K925744 is an FDA 510(k) clearance for the TEMPA-KUFF SINGLE PAT PRE-GAGED BALANCED DISP CUFF. Classified as Blood Pressure Cuff (product code DXQ), Class II - Special Controls.

Submitted by Pymah Corp. (Somerville, US). The FDA issued a Cleared decision on July 30, 1993 after a review of 259 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 Pymah Corp. devices

FDA 510(k) Submission Details - K925744

510(k) Number K925744 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 1992
Decision Date July 30, 1993
Days to Decision 259 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
134d slower than avg
Panel avg: 125d · This submission: 259d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 134
Devices cleared under the same product code (DXQ) and FDA review panel - the closest regulatory comparables to K925744.
RI-MED
K925297 · Rudolf Riester GmbH & Co. KG · Jan 1994
SLIMLINE 3000
K934180 · Pymah Corp. · Nov 1993
DISPOSABLE PENILE BLOOD PRESSURE CUFFS
K932851 · D. E. Hokanson, Inc. · Nov 1993
BALANCED(TM) NYLON BLADDER
K930604 · Pymah Corp. · Apr 1993
BLOOD PRESSURE CUFFS
K912638 · Vital Signs, Inc. · Jul 1991
ADULT,STERILE,DISPOS.,NONIVAS.,BLOOD PRESS. CUFFS
K905147 · Hewlett-Packard Co. · Dec 1990