Cleared Traditional

K822522 - CUTANEOUS PRESSURE PLETHYSMOGRAPH

K822522 is the FDA 510(k) clearance for CUTANEOUS PRESSURE PLETHYSMOGRAPH by Life Sciences Manufacturing, Inc.. It is a Class 2 Cardiovascular device (product code DSB) cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K822522 · Life Sciences Manufacturing, Inc. · Cardiovascular device
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Sep 1982
Decision
36d
Days
Class 2
Risk

K822522 is an FDA 510(k) clearance for the CUTANEOUS PRESSURE PLETHYSMOGRAPH. Classified as Plethysmograph, Impedance (product code DSB), Class II - Special Controls.

Submitted by Life Sciences Manufacturing, Inc.. The FDA issued a Cleared decision on September 28, 1982 after a review of 36 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Life Sciences Manufacturing, Inc. devices

Submission Details

510(k) Number K822522 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 1982
Decision Date September 28, 1982
Days to Decision 36 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
89d faster than avg
Panel avg: 125d · This submission: 36d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.