Cleared Traditional

K896415 - USCI PRESTO DISPOSABLE INFLATION DEVICE

K896415 is the FDA 510(k) clearance for USCI PRESTO DISPOSABLE INFLATION DEVICE by C.R. Bard, Inc.. It is a Class 2 Cardiovascular device (product code DXT) cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K896415 · C.R. Bard, Inc. · Cardiovascular device
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Jan 1990
Decision
72d
Days
Class 2
Risk

K896415 is an FDA 510(k) clearance for the USCI PRESTO DISPOSABLE INFLATION DEVICE. Classified as Injector And Syringe, Angiographic (product code DXT), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Billerica, US). The FDA issued a Cleared decision on January 19, 1990 after a review of 72 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1650 - 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 C.R. Bard, Inc. devices

Submission Details

510(k) Number K896415 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 1989
Decision Date January 19, 1990
Days to Decision 72 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
53d faster than avg
Panel avg: 125d · This submission: 72d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DXT Injector And Syringe, Angiographic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1650
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 - DXT Injector And Syringe, Angiographic

All 101
Devices cleared under the same product code (DXT) and FDA review panel - the closest regulatory comparables to K896415.
LIQUID DETECTOR
K903495 · Life-Tech Intl., Inc. · Oct 1990
MEDRAD MARK V-PLUS INJECTOR
K903390 · Medrad, Inc. · Sep 1990
B-D ANGIOGRAPHIC CONTROL SYRINGE
K895318 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jan 1990
HIGH PRESSURE CONNECTING SETS
K890208 · E-Z-Em, Inc. · May 1989
MERIT INTELLIFLATOR(TM) & MERIT MONITOR(TM)
K884913 · Merit Medical Systems, Inc. · Apr 1989
ACS INDEFLATOR P/T 20
K883452 · Advanced Cardiovascular Systems, Inc. · Oct 1988