510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K072757Substantially Equivalent

Dive and Shallow and Grand Dive

Summit to Sea, LLC., Mound MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K072757 is the FDA 510(k) clearance record for DIVE AND SHALLOW AND GRAND DIVE, a class II device, cleared for Summit TO Sea on under FDA product code CBF (Chamber, Hyperbaric). FDA records list one 510(k) clearance for Summit TO Sea. As of , FDA records show no recalls naming K072757.

Clearance record

Decision date
Received
(134 days to decision)
Product code
CBF Chamber, Hyperbaric
Regulation
21 CFR 868.5470
Device class
Class II
Review panel
Anesthesiology
Applicant
Summit TO Sea 1744 Avocet Ln., Mound MN
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