Cleared Traditional

THERMISTOR CANNULA STYLE,SINGLE ELEMENT,ADAM SHELL THERMISTOR AIRFLOW SENSOR (K960851) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K960851 · Pro-Tech Services, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1996
Decision
200d
Days
Class 2
Risk

K960851 is an FDA 510(k) clearance for the THERMISTOR CANNULA STYLE,SINGLE ELEMENT,ADAM SHELL THERMISTOR AIRFLOW SENSOR. Classified as Monitor, Breathing Frequency (product code BZQ), Class II - Special Controls.

Submitted by Pro-Tech Services, Inc. (Woodinville, US). The FDA issued a Cleared decision on September 17, 1996 after a review of 200 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 Pro-Tech Services, Inc. devices

Submission Details

510(k) Number K960851 FDA.gov
FDA Decision Cleared Substantially Equivalent - Third Party Review (ST)
Date Received March 01, 1996
Decision Date September 17, 1996
Days to Decision 200 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
60d slower than avg
Panel avg: 140d · This submission: 200d
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 35
Devices cleared under the same product code (BZQ) and FDA review panel - the closest regulatory comparables to K960851.
COVIDIEN NELLCOR RESPIRATION RATE SOFTWARE APPLICATION, VERSION 1.0
K111933 · Covidien · Mar 2012
BROWSER (EVENT SOFTWARE) MODEL # 4500E
K982550 · Respironics, Inc. · Oct 1998
COROMETRICS MODEL 510 AND 511 MONITOR
K962781 · Ge Medical Systems Information Technologies · Mar 1997
MODEL 510 INFANT MONITOR
K943308 · Ge Medical Systems Information Technologies · Jul 1995
MODEL 511 INFANT MONITOR
K942170 · Ge Medical Systems Information Technologies · Jun 1995
MRIDIAN MEDICAL SYSTEMS VENTLATOR HOSES
K925364 · Merit Medical Systems, Inc. · Jan 1993