Cleared Traditional

K911213 - CUFFABLE

K911213 is an FDA 510(k) clearance for CUFFABLE, manufactured by Biomedical Dynamics, Inc.. The device is a Class 2 Cardiovascular device with product code DXQ cleared through the Traditional 510(k) pathway after a 141-day FDA review.

K911213 · Biomedical Dynamics, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1991
Decision
141d
Days
Class 2
Risk

K911213 is an FDA 510(k) clearance for the CUFFABLE. Classified as Blood Pressure Cuff (product code DXQ), Class II - Special Controls.

Submitted by Biomedical Dynamics, Inc. (Burnsville, US). The FDA issued a Cleared decision on August 7, 1991 after a review of 141 days - within the typical 510(k) review window.

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 Biomedical Dynamics, Inc. devices

FDA 510(k) Submission Details - K911213

510(k) Number K911213 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 19, 1991
Decision Date August 07, 1991
Days to Decision 141 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
16d slower than avg
Panel avg: 125d · This submission: 141d
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 144
Devices cleared under the same product code (DXQ) and FDA review panel - the closest regulatory comparables to K911213.
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
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
NEONATAL/STERILE/DISPOS/NONINVAS BLOOD PRESS CUFF
K905101 · Hewlett-Packard Co. · Dec 1990