Cleared Traditional

K940014 - PLM SENSOR, MODEL PLM1

K940014 is an FDA 510(k) clearance for PLM SENSOR, manufactured by Pro-Tech, Inc.. The device is a Class 2 Anesthesiology device with product code BZQ cleared through the Traditional 510(k) pathway after a 310-day FDA review.

K940014 · Pro-Tech, Inc. · Anesthesiology device
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Nov 1994
Decision
310d
Days
Class 2
Risk

K940014 is an FDA 510(k) clearance for the PLM SENSOR, MODEL PLM1. Classified as Monitor, Breathing Frequency (product code BZQ), Class II - Special Controls.

Submitted by Pro-Tech, Inc. (Woodinville, US). The FDA issued a Cleared decision on November 10, 1994 after a review of 310 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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, Inc. devices

FDA 510(k) Submission Details - K940014

510(k) Number K940014 FDA.gov
FDA Decision Cleared Substantially Equivalent - Third Party Review (ST)
Date Received January 04, 1994
Decision Date November 10, 1994
Days to Decision 310 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
170d slower than avg
Panel avg: 140d · This submission: 310d
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 113
Devices cleared under the same product code (BZQ) and FDA review panel - the closest regulatory comparables to K940014.
OXIFLOW DIGITAL RECORDER
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K930790 · Bio-Logic Systems Corp. · Jan 1994
MODEL MEDILOG RAPIDE
K923737 · Oxford Medilog, Inc. · Jan 1994