Cleared Traditional

K903379 - PYMAH PRE-GAGED BALANCED TEMPA-KUFF

K903379 is an FDA 510(k) clearance for PYMAH PRE-GAGED BALANCED TEMPA-KUFF, 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 81-day FDA review.

K903379 · Pymah Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1990
Decision
81d
Days
Class 2
Risk

K903379 is an FDA 510(k) clearance for the PYMAH PRE-GAGED BALANCED TEMPA-KUFF. Classified as Blood Pressure Cuff (product code DXQ), Class II - Special Controls.

Submitted by Pymah Corp. (Potomac, US). The FDA issued a Cleared decision on October 19, 1990 after a review of 81 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Pymah Corp. devices

FDA 510(k) Submission Details - K903379

510(k) Number K903379 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 1990
Decision Date October 19, 1990
Days to Decision 81 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 125d · This submission: 81d
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 K903379.
BLOOD PRESSURE CUFFS
K912638 · Vital Signs, Inc. · Jul 1991
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
SURGI-CUF STERILE/NON-STERILE DISPOSABLE
K883977 · Ethox Corp. · Feb 1989
PRE-GAGED BALANCED CUFF W/SYLGARD ANTIMICRO. TREAT
K884421 · Pymah Corp. · Jan 1989