Cleared Traditional

K960121 - AUTOLINK BODY PLETHYSMOGRAPH

K960121 is the FDA 510(k) clearance for AUTOLINK BODY PLETHYSMOGRAPH by P.K. Morgan , Ltd.. It is a Class 2 Anesthesiology device (product code BZC) cleared through the Traditional 510(k) pathway after a 364-day FDA review.

K960121 · P.K. Morgan , Ltd. · Anesthesiology device
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Jan 1997
Decision
364d
Days
Class 2
Risk

K960121 is an FDA 510(k) clearance for the AUTOLINK BODY PLETHYSMOGRAPH. Classified as Calculator, Pulmonary Function Data (product code BZC), Class II - Special Controls.

Submitted by P.K. Morgan , Ltd. (Kent Rainham Me8 7ed, GB). The FDA issued a Cleared decision on January 9, 1997 after a review of 364 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1880 - 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. Elevated predicate reliance profile. 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 P.K. Morgan , Ltd. devices

Submission Details

510(k) Number K960121 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 11, 1996
Decision Date January 09, 1997
Days to Decision 364 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
224d slower than avg
Panel avg: 140d · This submission: 364d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code BZC Calculator, Pulmonary Function Data
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1880
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 - BZC Calculator, Pulmonary Function Data

All 8
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