Cleared Traditional

K820337 - IMPACT

K820337 is an FDA 510(k) clearance for IMPACT, manufactured by Impact Instrumentation, Inc.. The device is a Class 2 General Hospital device with product code GCX cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K820337 · Impact Instrumentation, Inc. · General Hospital
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Mar 1982
Decision
22d
Days
Class 2
Risk

K820337 is an FDA 510(k) clearance for the IMPACT, MODEL 303. Classified as Apparatus, Suction, Operating-room, Wall Vacuum Powered (product code GCX), Class II - Special Controls.

Submitted by Impact Instrumentation, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 2, 1982 after a review of 22 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 Impact Instrumentation, Inc. devices

FDA 510(k) Submission Details - K820337

510(k) Number K820337 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 1982
Decision Date March 02, 1982
Days to Decision 22 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
107d faster than avg
Panel avg: 129d · This submission: 22d
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 50
Devices cleared under the same product code (GCX) and FDA review panel - the closest regulatory comparables to K820337.
SPECIMEN COLLECTORS
K822005 · Kelleher Corp. · Jul 1982
THORACIC DRAINAGE SYSTEM
K821023 · Howmedica Corp. · May 1982
IMPACT, MODEL 310
K820424 · Impact Instrumentation, Inc. · Mar 1982
ASPIRATOR VENTURI SYSTEM MODEL 55-JV
K813319 · J. H. Emerson Co. · Dec 1981
SURGICAL SUCTION INSTRUMENTS-DISPOS.
K812845 · Abco Dealers, Inc. · Nov 1981
ARGYLE YANKAUER SUCTION TUBE
K813066 · Sherwood Medical Co. · Nov 1981