Cleared Special

K120880 - ORBIT

K120880 is an FDA 510(k) clearance for ORBIT, manufactured by National Biomedical, LLC Dba Qrs Diagnostic. The device is a Class 2 Anesthesiology device with product code BZG cleared through the Special 510(k) pathway after a 27-day FDA review.

K120880 · National Biomedical, LLC Dba Qrs Diagnostic · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2012
Decision
27d
Days
Class 2
Risk

K120880 is an FDA 510(k) clearance for the ORBIT. Classified as Spirometer, Diagnostic (product code BZG), Class II - Special Controls.

Submitted by National Biomedical, LLC Dba Qrs Diagnostic (Maple Grove, US). The FDA issued a Cleared decision on April 19, 2012 after a review of 27 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. 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.

FDA 510(k) Submission Details - K120880

510(k) Number K120880 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 2012
Decision Date April 19, 2012
Days to Decision 27 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
113d faster than avg
Panel avg: 140d · This submission: 27d
Pathway characteristics
Modification to existing cleared device.

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 158
Devices cleared under the same product code (BZG) and FDA review panel - the closest regulatory comparables to K120880.
SPIROTEL
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MINISPIR
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MICRO I
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SPIRODOC
K103530 · Medical International Research USA, Inc. · Nov 2011
CHARTIS CONSOLE
K111764 · Pulmonx, Inc. · Nov 2011