Cleared Traditional

K832656 - DINAMAP VITAL SIGNS MONITOR #1846P

K832656 is an FDA 510(k) clearance for DINAMAP VITAL SIGNS MONITOR #1846P, manufactured by Critikon Company, LLC. The device is a Class 2 Cardiovascular device with product code DXN cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K832656 · Critikon Company, LLC · Cardiovascular device
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Nov 1983
Decision
91d
Days
Class 2
Risk

K832656 is an FDA 510(k) clearance for the DINAMAP VITAL SIGNS MONITOR #1846P. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Critikon Company, LLC (Mchenry, US). The FDA issued a Cleared decision on November 7, 1983 after a review of 91 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 Critikon Company, LLC devices

FDA 510(k) Submission Details - K832656

510(k) Number K832656 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 1983
Decision Date November 07, 1983
Days to Decision 91 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
34d faster than avg
Panel avg: 125d · This submission: 91d
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 580
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K832656.
VERIFORM II
K833583 · American Medical Systems, Inc. · Jan 1984
ALPHA NON-INVASIVE BP CARDULE
K832764 · Spacelabs, Inc. · Jan 1984
NARCOTRACE 80
K830338 · Narco Scientific · Dec 1983
ACCU-SPHYG
K832060 · Olympic Medical Corp. · Oct 1983
LIFESTAT 200
K831232 · Physio-Control Corp. · Jul 1983
DINAMAP VITAL SIGNS MONITOR #1846
K831515 · Critikon Company, LLC · Jun 1983