Cleared Traditional

K970906 - PARATREND 7 MULTIPARAMETER SENIOR AND SATELLITE MONITOR SYSTEM WITH PARATREND 7 PLUS MULTIPARAMETER SENSOR

K970906 is an FDA 510(k) clearance for PARATREND 7 MULTIPARAMETER SENIOR AND S..., manufactured by Diametrics Medical, Ltd.. The device is a Class 2 Anesthesiology device with product code CBZ cleared through the Traditional 510(k) pathway after a 195-day FDA review.

K970906 · Diametrics Medical, Ltd. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1997
Decision
195d
Days
Class 2
Risk

K970906 is an FDA 510(k) clearance for the PARATREND 7 MULTIPARAMETER SENIOR AND SATELLITE MONITOR SYSTEM WITH PARATREND.... Classified as Analyzer, Ion, Hydrogen-ion (ph), Blood-phase, Indwelling (product code CBZ), Class II - Special Controls.

Submitted by Diametrics Medical, Ltd. (High Wycombe, Buckinghamshire, GB). The FDA issued a Cleared decision on September 23, 1997 after a review of 195 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1170 - 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 Diametrics Medical, Ltd. devices

FDA 510(k) Submission Details - K970906

510(k) Number K970906 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 1997
Decision Date September 23, 1997
Days to Decision 195 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
55d slower than avg
Panel avg: 140d · This submission: 195d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CBZ Device Classification - Class 2, Special Controls

Product Code CBZ Analyzer, Ion, Hydrogen-ion (ph), Blood-phase, Indwelling
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1170
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 - CBZ Analyzer, Ion, Hydrogen-ion (ph), Blood-phase, Indwelling

All 7
Devices cleared under the same product code (CBZ) and FDA review panel - the closest regulatory comparables to K970906.
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