510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K851480Substantially Equivalent

Vygon Guedel Airway 511 Vygon Bermann/orophar Airw

Vygon Corp., East Rutherford NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K851480 is the FDA 510(k) clearance record for VYGON GUEDEL AIRWAY 511 VYGON BERMANN/OROPHAR AIRW, a class II device, cleared for Vygon Corp. on under FDA product code LAE (High Pressure Liquid Chromatography, Codeine). FDA records list 13 510(k) clearances for Vygon Corp., from to . As of , FDA records show no recalls naming K851480.

Clearance record

Decision date
Received
(22 days to decision)
Product code
LAE High Pressure Liquid Chromatography, Codeine
Regulation
21 CFR 862.3270
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Vygon Corp. 1 Madison St., East Rutherford NJ
Third party review
No

Clearances, product code LAE

Trailing 12 months

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

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