510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K904396Substantially Equivalent

Simplex Neonatal Breathing Circuit System

Simplex Medical Systems, Inc., Las Vegas NV / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K904396 is the FDA 510(k) clearance record for SIMPLEX NEONATAL BREATHING CIRCUIT SYSTEM, a class II device, cleared for Simplex Medical Systems, Inc. on under FDA product code BZQ (Monitor, Breathing Frequency). FDA records list 3 510(k) clearances for Simplex Medical Systems, Inc., from to . As of , FDA records show no recalls naming K904396.

Clearance record

Decision date
Received
(161 days to decision)
Product code
BZQ Monitor, Breathing Frequency
Regulation
21 CFR 868.2375
Device class
Class II
Review panel
Anesthesiology
Applicant
Simplex Medical Systems, Inc. 3305 Springmountain Rd., #60, Las Vegas NV
Third party review
No

Clearances, product code BZQ

Trailing 12 months
2 clearances under product code BZQ in the twelve months to October 2026, June 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code BZQ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20262
July 20260
August 20260
September 20260
October 20260