Cleared Traditional

K871302 - MODEL 2000W OPTION H CONFIGURATION

K871302 is the FDA 510(k) clearance for MODEL 2000W OPTION H CONFIGURATION by Edentec Corp.. It is a Class 2 Anesthesiology device (product code BZQ) cleared through the Traditional 510(k) pathway after a 19-day FDA review.

K871302 · Edentec Corp. · Anesthesiology device
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Apr 1987
Decision
19d
Days
Class 2
Risk

K871302 is an FDA 510(k) clearance for the MODEL 2000W OPTION H CONFIGURATION. Classified as Monitor, Breathing Frequency (product code BZQ), Class II - Special Controls.

Submitted by Edentec Corp. (Eden Prairie, US). The FDA issued a Cleared decision on April 20, 1987 after a review of 19 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Edentec Corp. devices

Submission Details

510(k) Number K871302 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 1987
Decision Date April 20, 1987
Days to Decision 19 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
121d faster than avg
Panel avg: 140d · This submission: 19d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 36
Devices cleared under the same product code (BZQ) and FDA review panel - the closest regulatory comparables to K871302.
R-BAND(TM) RESPIRATORY SENSOR
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AR-800PA RESPIRATION MODULE
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MODEL 500E INFANT MONITORING SYSTEM
K873791 · Ge Medical Systems Information Technologies · Nov 1987
LIFESCOPE 6, OEC-6120 PORTABLE PATIENT MONITOR REC
K862462 · Nihon Kohden America, Inc. · Feb 1987
NEO-TRAK 502 INFANT MONITOR
K861407 · Ge Medical Systems Information Technologies · May 1986
COROMETRICS 500 INFANT MONITOR
K850504 · Ge Medical Systems Information Technologies · Jun 1985