510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K970046Substantially Equivalent

Universal Low Profile Nasal Hoods(1250,1275,1350,1450,1475,1550)

Accutron Inc, Phoenix AZ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K970046 is the FDA 510(k) clearance record for UNIVERSAL LOW PROFILE NASAL HOODS(1250,1275,1350,1450,1475,1550), a class I device, cleared for Accutron, Inc. on under FDA product code KHA (Mask, Scavenging). FDA records list 5 510(k) clearances for Accutron, Inc., from to . As of , FDA records show no recalls naming K970046.

Clearance record

Decision date
Received
(81 days to decision)
Product code
KHA Mask, Scavenging
Regulation
21 CFR 868.5590
Device class
Class I
Review panel
Anesthesiology
Applicant
Accutron, Inc. 2020 W. Melinda Ln., Phoenix AZ
510(k) summary
Statement
Third party review
No

Clearances, product code KHA

Trailing 12 months

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

FDA records show no clearances under product code KHA in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KHA, 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