Cleared Traditional

K072757 - DIVE AND SHALLOW AND GRAND DIVE

K072757 is an FDA 510(k) clearance for DIVE AND SHALLOW AND GRAND DIVE, manufactured by Summit TO Sea. The device is a Class 2 Anesthesiology device with product code CBF cleared through the Traditional 510(k) pathway after a 134-day FDA review.

K072757 · Summit TO Sea · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2008
Decision
134d
Days
Class 2
Risk

K072757 is an FDA 510(k) clearance for the DIVE AND SHALLOW AND GRAND DIVE. Classified as Chamber, Hyperbaric (product code CBF), Class II - Special Controls.

Submitted by Summit TO Sea (Mound, US). The FDA issued a Cleared decision on February 8, 2008 after a review of 134 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5470 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K072757

510(k) Number K072757 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2007
Decision Date February 08, 2008
Days to Decision 134 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
6d faster than avg
Panel avg: 140d · This submission: 134d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CBF Device Classification - Class 2, Special Controls

Product Code CBF Chamber, Hyperbaric
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5470
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Peers - CBF Chamber, Hyperbaric

All 56
Devices cleared under the same product code (CBF) and FDA review panel - the closest regulatory comparables to K072757.
RECTANGULAR MULTIPLACE HYPERBARIC CHAMBER
K082455 · Gulf Coast Hyperbarics, Inc. · May 2009
HYPERBARIC AMERICA, LLC, PRESIDENTIAL MONOPLACE HYPERBARIC CHAMBER SYSTEMS
K081506 · Hyperbaric America, LLC · Jul 2008
SIGMA SERIES HYPERBARIC CHAMBER
K072427 · Perry Baromedical Corp. · Jun 2008
MONOPLACE HYPERBARIC OXYGEN TREATMENT SYSTEM, MODEL BLKS-307
K060739 · Khrunichev State Research & Production Space Centr · Jul 2006
HYPEROX 101
K053498 · Wjo, Inc. · Mar 2006
OXYHEAL 1000 MONOPLACE HYPERBARIC CHAMBER
K052866 · Oxyheal Health Group · Dec 2005