Cleared Traditional

K833583 - VERIFORM II

K833583 is an FDA 510(k) clearance for VERIFORM II, manufactured by American Medical Systems, Inc.. The device is a Class 2 Cardiovascular device with product code DXN cleared through the Traditional 510(k) pathway after a 110-day FDA review.

K833583 · American Medical Systems, Inc. · Cardiovascular device
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Jan 1984
Decision
110d
Days
Class 2
Risk

K833583 is an FDA 510(k) clearance for the VERIFORM II. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by American Medical Systems, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 30, 1984 after a review of 110 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1130 - 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.

FDA 510(k) Submission Details - K833583

510(k) Number K833583 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 12, 1983
Decision Date January 30, 1984
Days to Decision 110 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
15d faster than avg
Panel avg: 125d · This submission: 110d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXN Device Classification - Class 2, Special Controls

Product Code DXN System, Measurement, Blood-pressure, Non-invasive
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1130
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 - DXN System, Measurement, Blood-pressure, Non-invasive

All 1206
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K833583.
DIGITAL SPHYGMOMANOMETER UA-251
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DIGITAL SPHGMOMANOMETER UA-271
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OMEGA 5000
K833978 · Invivo Research Labs, Inc. · Mar 1984
AC ADAPTERS FOR BLOOD PRESSURE METERS
K833753 · Philips Park · Jan 1984
ALPHA NON-INVASIVE BP CARDULE
K832764 · Spacelabs, Inc. · Jan 1984
NARCOTRACE 80
K830338 · Narco Scientific · Dec 1983
K833583 · VERIFORM II
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