Cleared Traditional

K833583 - VERIFORM II

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

K833583 · American Medical Systems, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

View all American Medical Systems, Inc. devices

Submission Details

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.

Device Classification

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 507
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K833583.
NON-INVASIVE BP MODULE 7000
K841336 · Marquette Electronics, Inc. · Oct 1984
DRAGER SPHYGMOMED
K840162 · Draeger Medical, Inc. · May 1984
TYCOS SELF CHECK BPM3 BLOOD PRESS MONI
K840469 · Sybron Corp. · May 1984
ALPHA NON-INVASIVE BP CARDULE
K832764 · Spacelabs, Inc. · Jan 1984
DINAMAP VITAL SIGNS MONITOR #1846P
K832656 · Critikon Company, LLC · Nov 1983
ACCU-SPHYG
K832060 · Olympic Medical Corp. · Oct 1983