Cleared Special

K010659 - SEA-LONG MEDICAL TREATMENT HOOD

K010659 is an FDA 510(k) clearance for SEA-LONG MEDICAL TREATMENT HOOD, manufactured by Sea-Long Medical Systems, Inc.. The device is a Class 2 Anesthesiology device with product code CBF cleared through the Special 510(k) pathway after a 71-day FDA review.

K010659 · Sea-Long Medical Systems, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2001
Decision
71d
Days
Class 2
Risk

K010659 is an FDA 510(k) clearance for the SEA-LONG MEDICAL TREATMENT HOOD. Classified as Chamber, Hyperbaric (product code CBF), Class II - Special Controls.

Submitted by Sea-Long Medical Systems, Inc. (Louisville, US). The FDA issued a Cleared decision on May 16, 2001 after a review of 71 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5470 - the FDA anesthesiology and respiratory device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K010659

510(k) Number K010659 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 2001
Decision Date May 16, 2001
Days to Decision 71 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
69d faster than avg
Panel avg: 140d · This submission: 71d
Pathway characteristics
Modification to existing cleared device.

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 68
Devices cleared under the same product code (CBF) and FDA review panel - the closest regulatory comparables to K010659.
OXYGEN APPLIED SYMPTOM IMPROVEMENT SYSTEM (OASIS)
K001121 · Engineered Medical Technology, Inc. · Nov 2001
INFANT OXYGEN TREATMENT HOOD
K011565 · Gulf Coast Hyperbarics, Inc. · Aug 2001
BLKS-303 MK MONOPLACE HYPERBARIC SYSTEM
K011312 · Khrunichev State Research & Production Space Centr · Jul 2001
MODEL 5000 MULTIPLACE HYPERBARIC THERAPY
K002794 · Hypertec, Inc. · Dec 2000
MODEL HYBRID 3200 MONOPLACE, HYPERBARIC THERAPY SYSTEMS
K002795 · Hypertec, Inc. · Dec 2000
GAMOW BAG, HYPER OXY, HYPER OXY P/T, PRESSURE-CIZER
K001409 · Hyperbaric Technologies, Inc. · Aug 2000
K010659 · SEA-LONG MEDICAL TREATMENT HOOD
Download PDF Sea-Long Medical Syst…