510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K844169Substantially Equivalent

Volumatic

Glaxo, Inc., Research Triangle NC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K844169 is the FDA 510(k) clearance record for VOLUMATIC, a class I device, cleared for Glaxo, Inc. on under FDA product code KCD (Bougie, Esophageal, Ent). FDA records list 3 510(k) clearances for Glaxo, Inc., from to . As of , FDA records show no recalls naming K844169.

Clearance record

Decision date
Received
(15 days to decision)
Product code
KCD Bougie, Esophageal, Ent
Regulation
21 CFR 874.4420
Device class
Class I
Review panel
Ear, Nose, Throat
Applicant
Glaxo, Inc. 5 Moore Dr., Research Triangle NC
Third party review
No

Clearances, product code KCD

Trailing 12 months

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

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