510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K842048Substantially Equivalent

Sun-One

Ensun Medical Products, Inc., Houston TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K842048 is the FDA 510(k) clearance record for SUN-ONE, a class II device, cleared for Ensun Medical Products, Inc. on under FDA product code BZQ (Monitor, Breathing Frequency). FDA records list one 510(k) clearance for Ensun Medical Products, Inc. As of , FDA records show no recalls naming K842048.

Clearance record

Decision date
Received
(163 days to decision)
Product code
BZQ Monitor, Breathing Frequency
Regulation
21 CFR 868.2375
Device class
Class II
Review panel
Anesthesiology
Applicant
Ensun Medical Products, Inc. 10011 W. Gulf Bank, Houston TX
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