Cleared Traditional

K951097 - BODYSTAY

K951097 is an FDA 510(k) clearance for BODYSTAY, manufactured by Bodystat , Ltd.. The device is a Class 2 Cardiovascular device with product code DSB cleared through the Traditional 510(k) pathway after a 259-day FDA review.

K951097 · Bodystat , Ltd. · Cardiovascular device
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Nov 1995
Decision
259d
Days
Class 2
Risk

K951097 is an FDA 510(k) clearance for the BODYSTAY. Classified as Plethysmograph, Impedance (product code DSB), Class II - Special Controls.

Submitted by Bodystat , Ltd. (British Isles, BR). The FDA issued a Cleared decision on November 22, 1995 after a review of 259 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2770 - the FDA cardiovascular device oversight 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 Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Bodystat , Ltd. devices

FDA 510(k) Submission Details - K951097

510(k) Number K951097 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 1995
Decision Date November 22, 1995
Days to Decision 259 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
134d slower than avg
Panel avg: 125d · This submission: 259d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DSB Device Classification - Class 2, Special Controls

Product Code DSB Plethysmograph, Impedance
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2770
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 Cardiovascular devices follow this clearance model.