510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K955535Substantially Equivalent

Louisville Labs Oxygen Head Tent

Louisville Laboratories, Inc., Louisville KY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K955535 is the FDA 510(k) clearance record for LOUISVILLE LABS OXYGEN HEAD TENT, a class II device, cleared for Louisville Laboratories, Inc. on under FDA product code CBF (Chamber, Hyperbaric). FDA records list 12 510(k) clearances for Louisville Laboratories, Inc., from to . As of , FDA records show no recalls naming K955535.

Clearance record

Decision date
Received
(209 days to decision)
Product code
CBF Chamber, Hyperbaric
Regulation
21 CFR 868.5470
Device class
Class II
Review panel
Anesthesiology
Applicant
Louisville Laboratories, Inc. 2400 Crittenden Dr., Louisville KY
510(k) summary
Statement
Third party review
No

Clearances, product code CBF

Trailing 12 months

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

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