510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K881264Substantially Equivalent

Perma Pure Nafion Tube Dryer-Model Me

Perma Pure Products, Inc., Toms River NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K881264 is the FDA 510(k) clearance record for PERMA PURE NAFION TUBE DRYER-MODEL ME, a class II device, cleared for Perma Pure Products, Inc. on under FDA product code CBQ (Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)). FDA records list one 510(k) clearance for Perma Pure Products, Inc. As of , FDA records show no recalls naming K881264.

Clearance record

Decision date
Received
(215 days to decision)
Product code
CBQ Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)
Regulation
21 CFR 868.1500
Device class
Class II
Review panel
Anesthesiology
Applicant
Perma Pure Products, Inc. 8 Executive Dr., Toms River NJ
Third party review
No

Clearances, product code CBQ

Trailing 12 months

FDA records hold no clearances under product code CBQ in the trailing twelve months.

FDA records show no clearances under product code CBQ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code CBQ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260