Cleared Traditional

K833674 - ACCURATE MEASUREMENT DEVICE KG-AMD

K833674 is the FDA 510(k) clearance for ACCURATE MEASUREMENT DEVICE KG-AMD by Sorensen Research. It is a Class 2 General Hospital device (product code GCX) cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K833674 · Sorensen Research · General Hospital
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Jan 1984
Decision
99d
Days
Class 2
Risk

K833674 is an FDA 510(k) clearance for the ACCURATE MEASUREMENT DEVICE KG-AMD. Classified as Apparatus, Suction, Operating-room, Wall Vacuum Powered (product code GCX), Class II - Special Controls.

Submitted by Sorensen Research (Walker, US). The FDA issued a Cleared decision on January 25, 1984 after a review of 99 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6740 - the FDA general hospital device 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 General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Sorensen Research devices

Submission Details

510(k) Number K833674 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 1983
Decision Date January 25, 1984
Days to Decision 99 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 129d · This submission: 99d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GCX Apparatus, Suction, Operating-room, Wall Vacuum Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6740
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 General Hospital devices follow this clearance model.

Regulatory Peers - GCX Apparatus, Suction, Operating-room, Wall Vacuum Powered

All 23
Devices cleared under the same product code (GCX) and FDA review panel - the closest regulatory comparables to K833674.
VAC-RITE
K885334 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 1989
OHMEDA POSI-PULSE SUCTION UNIT
K861261 · Ohmeda Medical · May 1986
MEDICAL/SURGICAL SUCTION SYSTEM
K851384 · Puritan Bennett Corp. · May 1985
ACCURATE MEASUREMENT DEVICE EZ-AMD
K833673 · Sorensen Research · Dec 1983
TALL FLOOR STAND TFS-01
K831939 · Sorensen Research · Jul 1983
PLEUR-EVAC A-4005 SYSTEM
K823037 · Howmedica Corp. · Oct 1982