Cleared Traditional

K896788 - DISP. NEONATAL BLOOD PRESSURE MONITORING CUFF

K896788 is an FDA 510(k) clearance for DISP. NEONATAL BLOOD PRESSURE MONITORIN..., manufactured by Advanced Medical Instruments, Inc.. The device is a Class 2 Cardiovascular device with product code DXQ cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K896788 · Advanced Medical Instruments, Inc. · Cardiovascular device
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Jan 1990
Decision
46d
Days
Class 2
Risk

K896788 is an FDA 510(k) clearance for the DISP. NEONATAL BLOOD PRESSURE MONITORING CUFF. Classified as Blood Pressure Cuff (product code DXQ), Class II - Special Controls.

Submitted by Advanced Medical Instruments, Inc. (Broken Arrow, US). The FDA issued a Cleared decision on January 19, 1990 after a review of 46 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 Advanced Medical Instruments, Inc. devices

FDA 510(k) Submission Details - K896788

510(k) Number K896788 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 1989
Decision Date January 19, 1990
Days to Decision 46 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
79d faster than avg
Panel avg: 125d · This submission: 46d
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 K896788.
NEONATAL/STERILE/DISPOS/NONINVAS BLOOD PRESS CUFF
K905101 · Hewlett-Packard Co. · Dec 1990
PYMAH PRE-GAGED BALANCED TEMPA-KUFF
K903379 · Pymah Corp. · Oct 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
C-FLO SUCTION TUBE
K882121 · Concept, Inc. · Jun 1988