Cleared Traditional

K022636 - BODY BOX 5500

K022636 is an FDA 510(k) clearance for BODY BOX 5500, manufactured by Morgan Scientific, Inc.. The device is a Class 2 Anesthesiology device with product code JEH cleared through the Traditional 510(k) pathway after a 158-day FDA review.

K022636 · Morgan Scientific, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2003
Decision
158d
Days
Class 2
Risk

K022636 is an FDA 510(k) clearance for the BODY BOX 5500. Classified as Plethysmograph, Volume (product code JEH), Class II - Special Controls.

Submitted by Morgan Scientific, Inc. (Haverhill, US). The FDA issued a Cleared decision on January 13, 2003 after a review of 158 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1760 - 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.

View all Morgan Scientific, Inc. devices

FDA 510(k) Submission Details - K022636

510(k) Number K022636 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 2002
Decision Date January 13, 2003
Days to Decision 158 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
18d slower than avg
Panel avg: 140d · This submission: 158d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JEH Device Classification - Class 2, Special Controls

Product Code JEH Plethysmograph, Volume
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1760
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.