Cleared Traditional

K791838 - HSH/H512 ADULT PHYSIOLOGICAL MONITORS

K791838 is an FDA 510(k) clearance for HSH/H512 ADULT PHYSIOLOGICAL MONITORS, manufactured by Medtel Pty. , Ltd.. The device is a Class 2 Cardiovascular device with product code DSK cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K791838 · Medtel Pty. , Ltd. · Cardiovascular device
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Oct 1979
Decision
17d
Days
Class 2
Risk

K791838 is an FDA 510(k) clearance for the HSH/H512 ADULT PHYSIOLOGICAL MONITORS. Classified as Computer, Blood-pressure (product code DSK), Class II - Special Controls.

Submitted by Medtel Pty. , Ltd. (Mchenry, US). The FDA issued a Cleared decision on October 1, 1979 after a review of 17 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1110 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Medtel Pty. , Ltd. devices

FDA 510(k) Submission Details - K791838

510(k) Number K791838 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 1979
Decision Date October 01, 1979
Days to Decision 17 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
108d faster than avg
Panel avg: 125d · This submission: 17d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DSK Device Classification - Class 2, Special Controls

Product Code DSK Computer, Blood-pressure
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1110
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 - DSK Computer, Blood-pressure

All 54
Devices cleared under the same product code (DSK) and FDA review panel - the closest regulatory comparables to K791838.
AMP PORTABLE PATIENT PRESSURE MONITOR
K802600 · American Medical Products, Inc. · Nov 1980
PRESSURE MONITOR, MODEL 1131B
K801110 · American Optical Corp. · May 1980
MODEL 1981 PRESSUROMETER DATA ANALYSIS
K792077 · Del Mar Avionics · Dec 1979
DINAMAP MODELS 1160 AND 1165
K782073 · Applied Medical Research · Feb 1979
MONITOR, PRESSURVEIL
K790135 · Concept, Inc. · Feb 1979
DINAMAP MODEL 846
K781053 · Applied Medical Research · Sep 1978