510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K963053Substantially Equivalent

9000 Series Filter & Filter/hme

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

K963053 is the FDA 510(k) clearance record for 9000 SERIES FILTER & FILTER/HME, a class II device, cleared for Enternet Medical, Inc. on under FDA product code CAH (Filter, Bacterial, Breathing-Circuit). FDA records list one 510(k) clearance for Enternet Medical, Inc. As of , FDA records show no recalls naming K963053.

Clearance record

Decision date
Received
(199 days to decision)
Product code
CAH Filter, Bacterial, Breathing-Circuit
Regulation
21 CFR 868.5260
Device class
Class II
Review panel
Anesthesiology
Applicant
Enternet Medical, Inc. 4542 E. Tropicana Ave. #100, Las Vegas NV
510(k) summary
Statement
Third party review
No

Clearances, product code CAH

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