Cleared Traditional

K954730 - BENCHMARK TRANSFER TEST

K954730 is an FDA 510(k) clearance for BENCHMARK TRANSFER TEST, manufactured by P.K. Morgan , Ltd.. The device is a Class 2 Anesthesiology device with product code BZC cleared through the Traditional 510(k) pathway after a 533-day FDA review.

K954730 · P.K. Morgan , Ltd. · Anesthesiology device
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Optimized for regulatory review, auditing and printing
Apr 1997
Decision
533d
Days
Class 2
Risk

K954730 is an FDA 510(k) clearance for the BENCHMARK TRANSFER TEST. 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 April 1, 1997 after a review of 533 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Anesthesiology submissions.

View all P.K. Morgan , Ltd. devices

FDA 510(k) Submission Details - K954730

510(k) Number K954730 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 16, 1995
Decision Date April 01, 1997
Days to Decision 533 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
393d slower than avg
Panel avg: 140d · This submission: 533d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BZC Device Classification - Class 2, Special Controls

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 34
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