Cleared Traditional

K833674 - ACCURATE MEASUREMENT DEVICE KG-AMD

K833674 is an FDA 510(k) clearance for ACCURATE MEASUREMENT DEVICE KG-AMD, manufactured by Sorensen Research. The device is a Class 2 General Hospital device with 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

FDA 510(k) Submission Details - K833674

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.

GCX Device Classification - Class 2, Special Controls

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 53
Devices cleared under the same product code (GCX) and FDA review panel - the closest regulatory comparables to K833674.
OHMEDA POSI-PULSE SUCTION UNIT
K861261 · Ohmeda Medical · May 1986
BOEHRINGER LABORATORIES SUCTION INTERMITTOR
K853095 · Boehringer Laboratories · Aug 1985
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