Cleared Special

K010659 - SEA-LONG MEDICAL TREATMENT HOOD (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K010659 · Sea-Long Medical Systems, Inc. · Anesthesiology device
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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.

View all Sea-Long Medical Systems, Inc. devices

Submission Details

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
Regulatory Context
Review time vs. panel average
68d faster than avg
Panel avg: 139d · This submission: 71d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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.