Cleared Abbreviated

K022062 - IMPACT, UNIVERSAL SINGLE-LIMB, VENTILATOR CIRCUIT, MODEL 820-0099-00 (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K022062 · Impact Instrumentation, Inc. · Anesthesiology device
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May 2003
Decision
315d
Days
Class 2
Risk

K022062 is an FDA 510(k) clearance for the IMPACT, UNIVERSAL SINGLE-LIMB, VENTILATOR CIRCUIT, MODEL 820-0099-00. Classified as Accessory To Continuous Ventilator (respirator) (product code MOD), Class II - Special Controls.

Submitted by Impact Instrumentation, Inc. (West Caldwell, US). The FDA issued a Cleared decision on May 6, 2003 after a review of 315 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5895 - the FDA anesthesiology and respiratory device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Impact Instrumentation, Inc. devices

Submission Details

510(k) Number K022062 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 2002
Decision Date May 06, 2003
Days to Decision 315 days
Submission Type Abbreviated
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
176d slower than avg
Panel avg: 139d · This submission: 315d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code MOD Accessory To Continuous Ventilator (respirator)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5895
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 Anesthesiology devices follow this clearance model.