Cleared Traditional

K851889 - CENTURION-II, MODEL 3103 APNEA/BRADY CARDIA TRACHY

K851889 is an FDA 510(k) clearance for CENTURION-II, manufactured by Clinical Data, Inc.. The device is a Class 2 Anesthesiology device with product code BZQ cleared through the Traditional 510(k) pathway after a 176-day FDA review.

K851889 · Clinical Data, Inc. · Anesthesiology device
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Oct 1985
Decision
176d
Days
Class 2
Risk

K851889 is an FDA 510(k) clearance for the CENTURION-II, MODEL 3103 APNEA/BRADY CARDIA TRACHY. Classified as Monitor, Breathing Frequency (product code BZQ), Class II - Special Controls.

Submitted by Clinical Data, Inc. (Boston, US). The FDA issued a Cleared decision on October 23, 1985 after a review of 176 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.2375 - 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 Clinical Data, Inc. devices

FDA 510(k) Submission Details - K851889

510(k) Number K851889 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 1985
Decision Date October 23, 1985
Days to Decision 176 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
36d slower than avg
Panel avg: 140d · This submission: 176d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BZQ Device Classification - Class 2, Special Controls

Product Code BZQ Monitor, Breathing Frequency
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.2375
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 - BZQ Monitor, Breathing Frequency

All 87
Devices cleared under the same product code (BZQ) and FDA review panel - the closest regulatory comparables to K851889.
MODEL 9000 RECORDING SYSTEM/RESPIRATION MONITORING
K860455 · Oxford Medilog, Inc. · Apr 1986
HEALTHDYNE'S EVENT RECORDER SYSTEM
K860254 · Healthdyne, Inc. · Jan 1986
MONAGHAN RVM, MODEL 760 OR MODEL 761
K853047 · Monaghan Medical Corp. · Nov 1985
MEDICON MODEL 8200 AMS(APNEA MONITOR SYSTEM)
K853084 · Aequitron Medical, Inc. · Aug 1985
EDENTEC MODEL 2000W APNEA MONITOR
K844327 · Edentec Corp. · Jul 1985
COROMETRICS 500 INFANT MONITOR
K850504 · Ge Medical Systems Information Technologies · Jun 1985