Cleared Traditional

TEMPA-KUFF SINGLE PAT PRE-GAGED BALANCED DISP CUFF (K925744) - FDA 510(k) Clearance

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

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

Submission Details

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
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.

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 197
Devices cleared under the same product code (DXQ) and FDA review panel - the closest regulatory comparables to K925744.
YP-710T Series NIBP Cuff
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