Cleared Traditional

K881264 - PERMA PURE NAFION TUBE DRYER-MODEL ME

K881264 is an FDA 510(k) clearance for PERMA PURE NAFION TUBE DRYER-MODEL ME, manufactured by Perma Pure Products, Inc.. The device is a Class 2 Anesthesiology device with product code CBQ cleared through the Traditional 510(k) pathway after a 215-day FDA review.

K881264 · Perma Pure Products, Inc. · Anesthesiology device
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Oct 1988
Decision
215d
Days
Class 2
Risk

K881264 is an FDA 510(k) clearance for the PERMA PURE NAFION TUBE DRYER-MODEL ME. Classified as Analyzer, Gas, Enflurane, Gaseous-phase (anesthetic Concentration) (product code CBQ), Class II - Special Controls.

Submitted by Perma Pure Products, Inc. (Toms River, US). The FDA issued a Cleared decision on October 25, 1988 after a review of 215 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1500 - 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.

FDA 510(k) Submission Details - K881264

510(k) Number K881264 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 1988
Decision Date October 25, 1988
Days to Decision 215 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
75d slower than avg
Panel avg: 140d · This submission: 215d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CBQ Device Classification - Class 2, Special Controls

Product Code CBQ Analyzer, Gas, Enflurane, Gaseous-phase (anesthetic Concentration)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1500
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 - CBQ Analyzer, Gas, Enflurane, Gaseous-phase (anesthetic Concentration)

All 19
Devices cleared under the same product code (CBQ) and FDA review panel - the closest regulatory comparables to K881264.
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K881264 · PERMA PURE NAFION TUBE DRYER-MODEL ME
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