Cleared Traditional

K850671 - IMPACT 901 SERIES PORT-A-WALL (FDA 510(k) Clearance)

Class I General Hospital device.

K850671 · Impact Instrumentation, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1985
Decision
19d
Days
Class 1
Risk

K850671 is an FDA 510(k) clearance for the IMPACT 901 SERIES PORT-A-WALL. Classified as Stand, Infusion (product code FOX), Class I - General Controls.

Submitted by Impact Instrumentation, Inc. (Bogota, US). The FDA issued a Cleared decision on March 11, 1985 after a review of 19 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6990 - 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

Submission Details

510(k) Number K850671 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 20, 1985
Decision Date March 11, 1985
Days to Decision 19 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
109d faster than avg
Panel avg: 128d · This submission: 19d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FOX Stand, Infusion
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6990
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.