Cleared Traditional

K896934 - KNIGHTWATCH SYSTEM

K896934 is an FDA 510(k) clearance for KNIGHTWATCH SYSTEM, manufactured by Createch Corp.. The device is a Class 2 Anesthesiology device with product code BZQ cleared through the Traditional 510(k) pathway after a 194-day FDA review.

K896934 · Createch Corp. · Anesthesiology device
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Jun 1990
Decision
194d
Days
Class 2
Risk

K896934 is an FDA 510(k) clearance for the KNIGHTWATCH SYSTEM. Classified as Monitor, Breathing Frequency (product code BZQ), Class II - Special Controls.

Submitted by Createch Corp. (Washington, D.C., US). The FDA issued a Cleared decision on June 25, 1990 after a review of 194 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.

FDA 510(k) Submission Details - K896934

510(k) Number K896934 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 1989
Decision Date June 25, 1990
Days to Decision 194 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
54d slower than avg
Panel avg: 140d · This submission: 194d
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 122
Devices cleared under the same product code (BZQ) and FDA review panel - the closest regulatory comparables to K896934.
TYPE 9240 ECG/RESP SYST ATHENA (ADULT & PEDIATIC)
K884120 · S & W Medico Teknik · Jul 1990
MODEL 9200 RESPIRATION/HEART RATE MONITOR
K901656 · Aequitron Medical, Inc. · Jul 1990
MODIFIED MODELS 9500,9550,9200,8200,HEART RATE MON
K902785 · Aequitron Medical, Inc. · Jul 1990
ARVEE APNEA MONITOR, MODEL 4800
K900730 · Arvee Medical, Inc. · Jun 1990
'APNEA-ELECTRODE'
K900826 · Medical Science Products, Inc. · Apr 1990
MESAM RECORDER
K894641 · Madaus Medtec, Inc. · Jan 1990
K896934 · KNIGHTWATCH SYSTEM
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