Cleared Traditional

K953795 - VITALMAX 4100

K953795 is an FDA 510(k) clearance for VITALMAX 4100, manufactured by Pace Tech, Inc.. The device is a Class 2 Anesthesiology device with product code CBS cleared through the Traditional 510(k) pathway after a 322-day FDA review.

K953795 · Pace Tech, Inc. · Anesthesiology device
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Jul 1996
Decision
322d
Days
Class 2
Risk

K953795 is an FDA 510(k) clearance for the VITALMAX 4100. Classified as Analyzer, Gas, Halothane, Gaseous-phase (anesthetic Conc.) (product code CBS), Class II - Special Controls.

Submitted by Pace Tech, Inc. (Clearwater, US). The FDA issued a Cleared decision on July 1, 1996 after a review of 322 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1620 - 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. Elevated predicate reliance profile. 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 Pace Tech, Inc. devices

FDA 510(k) Submission Details - K953795

510(k) Number K953795 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 1995
Decision Date July 01, 1996
Days to Decision 322 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
182d slower than avg
Panel avg: 140d · This submission: 322d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CBS Device Classification - Class 2, Special Controls

Product Code CBS Analyzer, Gas, Halothane, Gaseous-phase (anesthetic Conc.)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1620
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 - CBS Analyzer, Gas, Halothane, Gaseous-phase (anesthetic Conc.)

All 12
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