Cleared Traditional

K912007 - BAXTER SINGLE PATIENT USE BLOOD PRESSURE CUFF

K912007 is an FDA 510(k) clearance for BAXTER SINGLE PATIENT USE BLOOD PRESSUR..., manufactured by Tecnadyne Scientific, Inc.. The device is a Class 2 Cardiovascular device with product code DXQ cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K912007 · Tecnadyne Scientific, Inc. · Cardiovascular device
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Jul 1991
Decision
77d
Days
Class 2
Risk

K912007 is an FDA 510(k) clearance for the BAXTER SINGLE PATIENT USE BLOOD PRESSURE CUFF. Classified as Blood Pressure Cuff (product code DXQ), Class II - Special Controls.

Submitted by Tecnadyne Scientific, Inc. (Vero Beach, US). The FDA issued a Cleared decision on July 22, 1991 after a review of 77 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 Tecnadyne Scientific, Inc. devices

FDA 510(k) Submission Details - K912007

510(k) Number K912007 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 1991
Decision Date July 22, 1991
Days to Decision 77 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
48d faster than avg
Panel avg: 125d · This submission: 77d
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 147
Devices cleared under the same product code (DXQ) and FDA review panel - the closest regulatory comparables to K912007.
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
PYMAH PRE-GAGED BALANCED TEMPA-KUFF
K903379 · Pymah Corp. · Oct 1990