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
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

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
Combination Product No
PCCP Authorized No
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 186
Devices cleared under the same product code (BZG) and FDA review panel - the closest regulatory comparables to K001278.
COMPAS AS (COMPUTERIZED PULMONARY ANALYSIS SYSTEM)
K013752 · Morgan Scientific, Inc. · Jan 2002
SDI SB OFFICE, MODEL 29-
K011470 · Sdi Diagnostics, Inc. · Oct 2001
PC FLOW +
K001528 · Spirometrics Medical Equipment Co. · Jan 2001
BRENTWOOD IQMARK DIGITAL SPIROMETER (INCLUDES DISPOSABLE PNEUMOTACH MOUTHPIECES AND 3-LITER CALIBRATION SYRINGE
K002499 · Brentwood Medical Technology Corp. · Nov 2000
VITALOGRAPH BASE STATION
K000599 · Vitalograph, Inc. · Sep 2000
NDD MEDICAL TECHNOLOGIES EASYONE SPIROMETER: FRONTLINE MODEL 2000 AND DIAGNOSTIC MODEL 2001
K993921 · Ndd Medical Technologies · May 2000
K001278 · SENSAIRE DIAGNOSTIC SPIROMETER
Download PDF FDA Summary Qrs Diagnostic, LLC