Cleared Traditional

K884421 - PRE-GAGED BALANCED CUFF W/SYLGARD ANTIMICRO. TREAT

K884421 is an FDA 510(k) clearance for PRE-GAGED BALANCED CUFF W/SYLGARD ANTIM..., 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 85-day FDA review.

K884421 · Pymah Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1989
Decision
85d
Days
Class 2
Risk

K884421 is an FDA 510(k) clearance for the PRE-GAGED BALANCED CUFF W/SYLGARD ANTIMICRO. TREAT. 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 January 13, 1989 after a review of 85 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 - K884421

510(k) Number K884421 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 1988
Decision Date January 13, 1989
Days to Decision 85 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
40d faster than avg
Panel avg: 125d · This submission: 85d
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 K884421.
BLOOD PRESSURE CUFF
K896986 · Latex Medical Devices, Inc. · Mar 1990
DISP. NEONATAL BLOOD PRESSURE MONITORING CUFF
K896788 · Advanced Medical Instruments, Inc. · Jan 1990
SURGI-CUF STERILE/NON-STERILE DISPOSABLE
K883977 · Ethox Corp. · Feb 1989
BLOOD PRESSURE CUFF
K881799 · Biomedical Dynamics, Inc. · Oct 1988
C-FLO SUCTION TUBE
K882121 · Concept, Inc. · Jun 1988
BLOOD PRESSURE SLEEVE W/TUBING
K874233 · Devcom, Inc. · Mar 1988
K884421 · PRE-GAGED BALANCED CUFF W/SYLGARD ANTIMICRO. TREAT
Download PDF Pymah Corp.