Cleared Traditional

K944175 - ADAM SHELL THERMOCOUPLE ASSEMBLY

K944175 is an FDA 510(k) clearance for ADAM SHELL THERMOCOUPLE ASSEMBLY, manufactured by Pro-Tech Services, Inc.. The device is a Class 2 Anesthesiology device with product code BZG cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K944175 · Pro-Tech Services, Inc. · Anesthesiology device
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Oct 1994
Decision
49d
Days
Class 2
Risk

K944175 is an FDA 510(k) clearance for the ADAM SHELL THERMOCOUPLE ASSEMBLY. Classified as Spirometer, Diagnostic (product code BZG), Class II - Special Controls.

Submitted by Pro-Tech Services, Inc. (Woodinville, US). The FDA issued a Cleared decision on October 14, 1994 after a review of 49 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1840 - 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 Pro-Tech Services, Inc. devices

FDA 510(k) Submission Details - K944175

510(k) Number K944175 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 1994
Decision Date October 14, 1994
Days to Decision 49 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
91d faster than avg
Panel avg: 140d · This submission: 49d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BZG Device Classification - Class 2, Special Controls

Product Code BZG Spirometer, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1840
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 - BZG Spirometer, Diagnostic

All 56
Devices cleared under the same product code (BZG) and FDA review panel - the closest regulatory comparables to K944175.
SPIROMETER MODEL NPB-500
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PURITAN-BENNETT RENAISSANCE SPIROMETRY SYSTEMWITH THE OPTIONALRENAISSANCE DB DATA MANAGEMENTSOFTWARE
K944762 · Puritan Bennett Corp. · Dec 1994
L.A.P. II SPRIOMETRY SYSTEM
K932936 · Allied Healthcare Products, Inc. · Feb 1994
SENSORMEDICS MODEL 2200 PULMONARY FUNCTION LABS
K923988 · Sensor Medics Corp. · Oct 1993
SENSORMEDICS MODEL 6200 AUTOBOX DL
K923989 · Sensor Medics Corp. · Aug 1993