510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K851082Substantially Equivalent

V. Mueller Blom-Singer Esophageal Insufflation Tes

American V. Mueller, Chicago IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K851082 is the FDA 510(k) clearance record for V. MUELLER BLOM-SINGER ESOPHAGEAL INSUFFLATION TES, a class I device, cleared for American V. Mueller on under FDA product code ENW (Catheter, Nasopharyngeal). FDA records list 31 510(k) clearances for American V. Mueller, from to . As of , FDA records show no recalls naming K851082.

Clearance record

Decision date
Received
(126 days to decision)
Product code
ENW Catheter, Nasopharyngeal
Regulation
21 CFR 874.4175
Device class
Class I
Review panel
Ear, Nose, Throat
Applicant
American V. Mueller 6600 W. Touhy, Chicago IL
Third party review
No

Clearances, product code ENW

Trailing 12 months

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

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