Cleared Traditional

K871302 - MODEL 2000W OPTION H CONFIGURATION

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

K871302 · Edentec Corp. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K871302

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
Combination Product No
PCCP Authorized No
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.

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 86
Devices cleared under the same product code (BZQ) and FDA review panel - the closest regulatory comparables to K871302.
MODEL 500E INFANT MONITORING SYSTEM
K873791 · Ge Medical Systems Information Technologies · Nov 1987
MODEL NUMBER 9216 RESPIRATION/HEART RATE MONITOR
K872954 · Aequitron Medical, Inc. · Oct 1987
MODEL NUMBER 8200 RESPIRATION/HEART RATE MONITOR
K871551 · Aequitron Medical, Inc. · Jun 1987
LIFEWATCH PLUS
K870661 · The Perkin-Elmer Corp. · Mar 1987
LIFESCOPE 6, OEC-6120 PORTABLE PATIENT MONITOR REC
K862462 · Nihon Kohden America, Inc. · Feb 1987
KONTRON VITALMON 5010 PATIENT MONITOR
K852249 · Kontron Instruments, Inc. · Oct 1986