510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K031649Substantially Equivalent

Sl8/dl8/tl20 Hyperbaric Oxygen Treatment Facilities

Fink Engineering Pty Ltd, San Antonio TX / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K031649 is the FDA 510(k) clearance record for SL8/DL8/TL20 HYPERBARIC OXYGEN TREATMENT FACILITIES, a class II device, cleared for Fink Engineering Pty, Ltd. on under FDA product code CBF (Chamber, Hyperbaric). FDA records list 2 510(k) clearances for Fink Engineering Pty, Ltd., from to . As of , FDA records show no recalls naming K031649.

Clearance record

Decision date
Received
(191 days to decision)
Product code
CBF Chamber, Hyperbaric
Regulation
21 CFR 868.5470
Device class
Class II
Review panel
Anesthesiology
Applicant
Fink Engineering Pty, Ltd. 18111 Copper Ridge Dr., San Antonio TX
510(k) summary
Summary PDF
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