Cleared Special

K092685 - PNEUMOTHERML

K092685 is an FDA 510(k) clearance for PNEUMOTHERML, manufactured by Salter Labs. The device is a Class 2 Anesthesiology device with product code BZQ cleared through the Special 510(k) pathway after a 83-day FDA review.

K092685 · Salter Labs · Anesthesiology device
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Nov 2009
Decision
83d
Days
Class 2
Risk

K092685 is an FDA 510(k) clearance for the PNEUMOTHERML, MODEL: 5800. Classified as Monitor, Breathing Frequency (product code BZQ), Class II - Special Controls.

Submitted by Salter Labs (Arvin, US). The FDA issued a Cleared decision on November 24, 2009 after a review of 83 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Salter Labs devices

FDA 510(k) Submission Details - K092685

510(k) Number K092685 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 02, 2009
Decision Date November 24, 2009
Days to Decision 83 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
57d faster than avg
Panel avg: 140d · This submission: 83d
Pathway characteristics
Modification to existing cleared device.

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 77
Devices cleared under the same product code (BZQ) and FDA review panel - the closest regulatory comparables to K092685.
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