510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K881451Substantially Equivalent

Simplex Universal Heated Tubing Sleeve

Simplex Medical Corp., Riverside CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K881451 is the FDA 510(k) clearance record for SIMPLEX UNIVERSAL HEATED TUBING SLEEVE, a class II device, cleared for Simplex Medical Corp. on under FDA product code BZE (Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer). FDA records list one 510(k) clearance for Simplex Medical Corp. As of , FDA records show no recalls naming K881451.

Clearance record

Decision date
Received
(65 days to decision)
Product code
BZE Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
Regulation
21 CFR 868.5270
Device class
Class II
Review panel
Anesthesiology
Applicant
Simplex Medical Corp. 8920 Limonite, Suite 291, Riverside CA
Third party review
No

Clearances, product code BZE

Trailing 12 months
2 clearances under product code BZE in the twelve months to October 2026, March 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code BZE, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20261
April 20260
May 20260
June 20261
July 20260
August 20260
September 20260
October 20260