Cleared Traditional

K930604 - BALANCED(TM) NYLON BLADDER

K930604 is an FDA 510(k) clearance for BALANCED(TM) NYLON BLADDER, 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 84-day FDA review.

K930604 · Pymah Corp. · Cardiovascular device
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Apr 1993
Decision
84d
Days
Class 2
Risk

K930604 is an FDA 510(k) clearance for the BALANCED(TM) NYLON BLADDER. 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 April 30, 1993 after a review of 84 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.

FDA 510(k) Submission Details - K930604

510(k) Number K930604 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 1993
Decision Date April 30, 1993
Days to Decision 84 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
41d faster than avg
Panel avg: 125d · This submission: 84d
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 198
Devices cleared under the same product code (DXQ) and FDA review panel - the closest regulatory comparables to K930604.
DISPOSABLE PENILE BLOOD PRESSURE CUFFS
K932851 · D. E. Hokanson, Inc. · Nov 1993
TEMPA-KUFF SINGLE PAT PRE-GAGED BALANCED DISP CUFF
K925744 · Pymah Corp. · Jul 1993
CLEANCUFF(TM)
K931087 · Med-Con, Inc. · May 1993
CLEAN CUFF BLOOD PRESSURE CUFF LINER
K925352 · Steridyne Corp. · Jan 1993
CUFF-M
K921997 · Lorin Medical, Inc. · Jul 1992
CUFFABLE
K911213 · Biomedical Dynamics, Inc. · Aug 1991
K930604 · BALANCED(TM) NYLON BLADDER
Download PDF Pymah Corp.