Cleared Traditional

K830343 - CONTAINER W/PRIMING SOLUTION

K830343 is an FDA 510(k) clearance for CONTAINER W/PRIMING SOLUTION, manufactured by American Hospital Supply Corp.. The device is a Class 2 General Hospital device with product code KDP cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K830343 · American Hospital Supply Corp. · General Hospital
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Mar 1983
Decision
44d
Days
Class 2
Risk

K830343 is an FDA 510(k) clearance for the CONTAINER W/PRIMING SOLUTION. Classified as Regulator, Vacuum (product code KDP), Class II - Special Controls.

Submitted by American Hospital Supply Corp. (Mchenry, US). The FDA issued a Cleared decision on March 17, 1983 after a review of 44 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 American Hospital Supply Corp. devices

FDA 510(k) Submission Details - K830343

510(k) Number K830343 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 1983
Decision Date March 17, 1983
Days to Decision 44 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
85d faster than avg
Panel avg: 129d · This submission: 44d
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 K830343.
SUCTION REGULATOR 7700 SERIES
K850200 · Boehringer Laboratories · Mar 1985
INTERCEPT
K843591 · Vital Signs, Inc. · Oct 1984
THORACIC GAUGE #TG-60 -VACUUM REGULATOR
K831505 · Sorensen Research · Jul 1983
WATERLESS SEAL & VACUUM REGULATOR
K820706 · Sorensen Research · Apr 1982
EMERSON THORACIC SUCTION REG. #55-JP
K820077 · J. H. Emerson Co. · Jan 1982
OHIO FREE FLOW VACUUM REGULATOR
K801169 · Ohio Medical Products · Jul 1980