Cleared Traditional

K831939 - TALL FLOOR STAND TFS-01

K831939 is the FDA 510(k) clearance for TALL FLOOR STAND TFS-01 by Sorensen Research. It is a Class 2 General Hospital device (product code GCX) cleared through the Traditional 510(k) pathway after a 33-day FDA review.

K831939 · Sorensen Research · General Hospital
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Jul 1983
Decision
33d
Days
Class 2
Risk

K831939 is an FDA 510(k) clearance for the TALL FLOOR STAND TFS-01. Classified as Apparatus, Suction, Operating-room, Wall Vacuum Powered (product code GCX), Class II - Special Controls.

Submitted by Sorensen Research (Mchenry, US). The FDA issued a Cleared decision on July 19, 1983 after a review of 33 days - a notably fast clearance cycle.

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: 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 Sorensen Research devices

Submission Details

510(k) Number K831939 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 1983
Decision Date July 19, 1983
Days to Decision 33 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
96d faster than avg
Panel avg: 129d · This submission: 33d
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 K831939.
MEDICAL/SURGICAL SUCTION SYSTEM
K851384 · Puritan Bennett Corp. · May 1985
ACCURATE MEASUREMENT DEVICE KG-AMD
K833674 · Sorensen Research · Jan 1984
ACCURATE MEASUREMENT DEVICE EZ-AMD
K833673 · Sorensen Research · Dec 1983
PLEUR-EVAC A-4005 SYSTEM
K823037 · Howmedica Corp. · Oct 1982
SPECIMEN COLLECTORS
K822005 · Kelleher Corp. · Jul 1982
THORACIC DRAINAGE SYSTEM
K821023 · Howmedica Corp. · May 1982