Cleared Traditional

K935546 - MAC/IV SEDATION KIT (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K935546 · Vital Signs, Inc. · Anesthesiology device
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Jun 1994
Decision
208d
Days
Class 2
Risk

K935546 is an FDA 510(k) clearance for the MAC/IV SEDATION KIT. Classified as Gas-machine, Anesthesia (product code BSZ), Class II - Special Controls.

Submitted by Vital Signs, Inc. (Totowa, US). The FDA issued a Cleared decision on June 13, 1994 after a review of 208 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5160 - 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 Vital Signs, Inc. devices

Submission Details

510(k) Number K935546 FDA.gov
FDA Decision Cleared Substantially Equivalent - De Novo Granted (SEKD)
Date Received November 17, 1993
Decision Date June 13, 1994
Days to Decision 208 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
69d slower than avg
Panel avg: 139d · This submission: 208d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code BSZ Gas-machine, Anesthesia
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5160
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 - BSZ Gas-machine, Anesthesia

All 186
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