Cleared Traditional

K854310 - ACS INDEFLATOR (MODIFICATION)

K854310 is the FDA 510(k) clearance for ACS INDEFLATOR (MODIFICATION) by Advanced Cardiovascular Systems, Inc.. It is a Class 2 Cardiovascular device (product code DXT) cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K854310 · Advanced Cardiovascular Systems, Inc. · Cardiovascular device
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Dec 1985
Decision
41d
Days
Class 2
Risk

K854310 is an FDA 510(k) clearance for the ACS INDEFLATOR (MODIFICATION). Classified as Injector And Syringe, Angiographic (product code DXT), Class II - Special Controls.

Submitted by Advanced Cardiovascular Systems, Inc. (Mountain View, US). The FDA issued a Cleared decision on December 4, 1985 after a review of 41 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 Advanced Cardiovascular Systems, Inc. devices

Submission Details

510(k) Number K854310 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 24, 1985
Decision Date December 04, 1985
Days to Decision 41 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
84d faster than avg
Panel avg: 125d · This submission: 41d
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 K854310.
MECHANICAL INFLATION DEVICE
K862547 · American Edwards Laboratories · Sep 1986
ANGIOJECT
K860842 · Target Therapeutics · Apr 1986
ROENTGENOGRAPHY SET & PRESSURE MONITORING LINE
K850861 · Medical Components, Inc. · Feb 1986
LEVEEN INFLATOR DISPOSABLE INFLATION SYRINGE
K851402 · Medi-Tech, Inc. · Jun 1985
ADVANCED CARDIOVASCULAR SYSTEMS ANGIOJECT
K844045 · Advanced Cardiovascular Systems, Inc. · Nov 1984
CONTRAST MEDIA INJECT. SET CMS
K833645 · Gish Biomedical, Inc. · Apr 1984