Cleared Traditional

K001278 - SENSAIRE DIAGNOSTIC SPIROMETER

K001278 is an FDA 510(k) clearance for SENSAIRE DIAGNOSTIC SPIROMETER, manufactured by Qrs Diagnostic, LLC. The device is a Class 2 Anesthesiology device with product code BZG cleared through the Traditional 510(k) pathway after a 222-day FDA review.

K001278 · Qrs Diagnostic, LLC · Anesthesiology device
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Nov 2000
Decision
222d
Days
Class 2
Risk

K001278 is an FDA 510(k) clearance for the SENSAIRE DIAGNOSTIC SPIROMETER. Classified as Spirometer, Diagnostic (product code BZG), Class II - Special Controls.

Submitted by Qrs Diagnostic, LLC (Plymouth, US). The FDA issued a Cleared decision on November 29, 2000 after a review of 222 days - an extended review 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: 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 Qrs Diagnostic, LLC devices

FDA 510(k) Submission Details - K001278

510(k) Number K001278 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 21, 2000
Decision Date November 29, 2000
Days to Decision 222 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
82d slower than avg
Panel avg: 140d · This submission: 222d
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 70
Devices cleared under the same product code (BZG) and FDA review panel - the closest regulatory comparables to K001278.
PURITAN BENNETT DATAFLOW DATA MANAGEMENT SOFTWARE
K023225 · Puritan Bennett Corp. · Dec 2002
PURITAN-BENNETT 700 RENAISSANCE II SPIROMETRY SYSTEM
K022103 · Puritan Bennett Corp. · Sep 2002
EMS PULMONARY FUNCTION TESTING FILTER
K013123 · Engineered Medical Systems · Mar 2002
SPIROVIT SP-2, PNEUMOCHECK II
K992823 · Schiller AG · May 2000
SPIROVIT, MODEL SP-250
K984031 · Schiller AG · Apr 1999
CAIRD TECHNOLOGY SPIROMETER
K971336 · Caird Technology · Dec 1998