Cleared Traditional

K833799 - SPHYGOMANO METER

K833799 is the FDA 510(k) clearance for SPHYGOMANO METER by Fraser Harlake, Inc.. It is a Class 2 Cardiovascular device (product code DXN) cleared through the Traditional 510(k) pathway after a 195-day FDA review.

K833799 · Fraser Harlake, Inc. · Cardiovascular device
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May 1984
Decision
195d
Days
Class 2
Risk

K833799 is an FDA 510(k) clearance for the SPHYGOMANO METER. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Fraser Harlake, Inc. (Walker, US). The FDA issued a Cleared decision on May 14, 1984 after a review of 195 days - an extended review cycle.

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 Fraser Harlake, Inc. devices

Submission Details

510(k) Number K833799 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 1983
Decision Date May 14, 1984
Days to Decision 195 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
70d slower than avg
Panel avg: 125d · This submission: 195d
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 389
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K833799.
MUSE-DP
K840932 · Marquette Electronics, Inc. · Oct 1984
NON-INVASIVE BP MODULE 7000
K841336 · Marquette Electronics, Inc. · Oct 1984
DRAGER SPHYGMOMED
K840162 · Draeger Medical, Inc. · May 1984
VERIFORM II
K833583 · American Medical Systems, Inc. · Jan 1984
LIFESTAT 200
K831232 · Physio-Control Corp. · Jul 1983
IVAC #1160 MULTIPLE VITAL SIGNS UNIT
K820569 · Y · Mar 1982