Cleared Traditional

K831505 - THORACIC GAUGE #TG-60 -VACUUM REGULATOR

K831505 is an FDA 510(k) clearance for THORACIC GAUGE #TG-60 -VACUUM REGULATOR, manufactured by Sorensen Research. The device is a Class 2 General Hospital device with product code KDP cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K831505 · Sorensen Research · General Hospital
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Jul 1983
Decision
62d
Days
Class 2
Risk

K831505 is an FDA 510(k) clearance for the THORACIC GAUGE #TG-60 -VACUUM REGULATOR. Classified as Regulator, Vacuum (product code KDP), Class II - Special Controls.

Submitted by Sorensen Research (Mchenry, US). The FDA issued a Cleared decision on July 12, 1983 after a review of 62 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

FDA 510(k) Submission Details - K831505

510(k) Number K831505 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 1983
Decision Date July 12, 1983
Days to Decision 62 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
67d faster than avg
Panel avg: 129d · This submission: 62d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KDP Device Classification - Class 2, Special Controls

Product Code KDP Regulator, Vacuum
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 - KDP Regulator, Vacuum

All 14
Devices cleared under the same product code (KDP) and FDA review panel - the closest regulatory comparables to K831505.
BOEHRINGER LAB SUCTION INTERRUPTER
K853155 · Boehringer Laboratories · Oct 1985
SUCTION REGULATOR 7700 SERIES
K850200 · Boehringer Laboratories · Mar 1985
INTERCEPT
K843591 · Vital Signs, Inc. · Oct 1984
CONTAINER W/PRIMING SOLUTION
K830343 · American Hospital Supply Corp. · Mar 1983
WATERLESS SEAL & VACUUM REGULATOR
K820706 · Sorensen Research · Apr 1982
EMERSON THORACIC SUCTION REG. #55-JP
K820077 · J. H. Emerson Co. · Jan 1982