Cleared Traditional

K830754 - BLOOD PRESSURE MONITORING KITS

K830754 is the FDA 510(k) clearance for BLOOD PRESSURE MONITORING KITS by Medical Parameters, Inc.. It is a Class 2 Cardiovascular device (product code DXT) cleared through the Traditional 510(k) pathway after a 155-day FDA review.

K830754 · Medical Parameters, Inc. · Cardiovascular device
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Aug 1983
Decision
155d
Days
Class 2
Risk

K830754 is an FDA 510(k) clearance for the BLOOD PRESSURE MONITORING KITS,WALRUS. Classified as Injector And Syringe, Angiographic (product code DXT), Class II - Special Controls.

Submitted by Medical Parameters, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 12, 1983 after a review of 155 days - an extended review 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: 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 Medical Parameters, Inc. devices

Submission Details

510(k) Number K830754 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 1983
Decision Date August 12, 1983
Days to Decision 155 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
30d slower than avg
Panel avg: 125d · This submission: 155d
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 96
Devices cleared under the same product code (DXT) and FDA review panel - the closest regulatory comparables to K830754.
CONTRAST MEDIA INJECT. SET CMS
K833645 · Gish Biomedical, Inc. · Apr 1984
ANGIOGRAPHIC DRAPE PACKS
K840281 · Medrad, Inc. · Apr 1984
ANGIOPLASTY INFLATION DEVICE & CARTR
K834107 · Cordis Corp. · Jan 1984
MARK V
K822536 · Medrad, Inc. · Sep 1982
QUICK FILL
K800823 · Medrad, Inc. · Apr 1980
ANGIOPLASTY INJECTOR
K800613 · Medrad, Inc. · Apr 1980