510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K801938Substantially Equivalent

Rhinometer

Aztec Medical Products, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K801938 is the FDA 510(k) clearance record for RHINOMETER, a class I device, cleared for Aztec Medical Products, Inc. on under FDA product code JYJ (Gauge, Measuring). FDA records list 5 510(k) clearances for Aztec Medical Products, Inc., from to . As of , FDA records show no recalls naming K801938.

Clearance record

Decision date
Received
(28 days to decision)
Product code
JYJ Gauge, Measuring
Regulation
21 CFR 874.4420
Device class
Class I
Review panel
Ear, Nose, Throat
Applicant
Aztec Medical Products, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code JYJ

Trailing 12 months

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

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