Cleared Traditional

K841893 - MAXAMAN

K841893 is an FDA 510(k) clearance for MAXAMAN, manufactured by Cryo2 Corp.. The device is a Class 2 Anesthesiology device with product code BTL cleared through the Traditional 510(k) pathway after a 115-day FDA review.

K841893 · Cryo2 Corp. · Anesthesiology device
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Aug 1984
Decision
115d
Days
Class 2
Risk

K841893 is an FDA 510(k) clearance for the MAXAMAN. Classified as Ventilator, Emergency, Powered (resuscitator) (product code BTL), Class II - Special Controls.

Submitted by Cryo2 Corp. (Walker, US). The FDA issued a Cleared decision on August 30, 1984 after a review of 115 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5925 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Cryo2 Corp. devices

FDA 510(k) Submission Details - K841893

510(k) Number K841893 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 1984
Decision Date August 30, 1984
Days to Decision 115 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 140d · This submission: 115d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BTL Device Classification - Class 2, Special Controls

Product Code BTL Ventilator, Emergency, Powered (resuscitator)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5925
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 - BTL Ventilator, Emergency, Powered (resuscitator)

All 78
Devices cleared under the same product code (BTL) and FDA review panel - the closest regulatory comparables to K841893.
IMPACT MODELS 701, 702 AND 703
K861272 · Impact Instrumentation, Inc. · May 1986
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K860077 · Instrumentation Industries, Inc. · Feb 1986
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K851337 · Life Support Products, Inc. · May 1985
PNEUPAC OXYGEN THERAPY UNIT
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