510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K834078Substantially Equivalent

Silicone Rugger Disposable Yoke-CPAP

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

K834078 is the FDA 510(k) clearance record for SILICONE RUGGER DISPOSABLE YOKE-CPAP, a class I device, cleared for Vesta, Inc. on under FDA product code BTQ (Airway, Nasopharyngeal). FDA records list 4 510(k) clearances for Vesta, Inc., from to . As of , FDA records show no recalls naming K834078.

Clearance record

Decision date
Received
(29 days to decision)
Product code
BTQ Airway, Nasopharyngeal
Regulation
21 CFR 868.5100
Device class
Class I
Review panel
Anesthesiology
Applicant
Vesta, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code BTQ

Trailing 12 months

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

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