Cleared Traditional

K841537 - IMPACT MODEL 601

K841537 is an FDA 510(k) clearance for IMPACT MODEL 601, manufactured by Impact Instrumentation, Inc.. The device is a Class 2 Anesthesiology device with product code BTI cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K841537 · Impact Instrumentation, Inc. · Anesthesiology device
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May 1984
Decision
45d
Days
Class 2
Risk

K841537 is an FDA 510(k) clearance for the IMPACT MODEL 601. Classified as Compressor, Air, Portable (product code BTI), Class II - Special Controls.

Submitted by Impact Instrumentation, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 31, 1984 after a review of 45 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.6250 - the FDA anesthesiology and respiratory 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 - K841537

510(k) Number K841537 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 1984
Decision Date May 31, 1984
Days to Decision 45 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 140d · This submission: 45d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BTI Device Classification - Class 2, Special Controls

Product Code BTI Compressor, Air, Portable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.6250
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.

Regulatory Peers - BTI Compressor, Air, Portable

All 19
Devices cleared under the same product code (BTI) and FDA review panel - the closest regulatory comparables to K841537.
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