Cleared Traditional

K002499 - BRENTWOOD IQMARK DIGITAL SPIROMETER (INCLUDES DISPOSABLE PNEUMOTACH MOUTHPIECES AND 3-LITER CALIBRATION SYRINGE

K002499 is an FDA 510(k) clearance for BRENTWOOD IQMARK DIGITAL SPIROMETER (IN..., manufactured by Brentwood Medical Technology Corp.. The device is a Class 2 Anesthesiology device with product code BZG cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K002499 · Brentwood Medical Technology Corp. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2000
Decision
86d
Days
Class 2
Risk

K002499 is an FDA 510(k) clearance for the BRENTWOOD IQMARK DIGITAL SPIROMETER (INCLUDES DISPOSABLE PNEUMOTACH MOUTHPIEC.... Classified as Spirometer, Diagnostic (product code BZG), Class II - Special Controls.

Submitted by Brentwood Medical Technology Corp. (Torrance, US). The FDA issued a Cleared decision on November 8, 2000 after a review of 86 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K002499

510(k) Number K002499 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 2000
Decision Date November 08, 2000
Days to Decision 86 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
54d faster than avg
Panel avg: 140d · This submission: 86d
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 K002499.
SDI SB OFFICE, MODEL 29-
K011470 · Sdi Diagnostics, Inc. · Oct 2001
PC FLOW +
K001528 · Spirometrics Medical Equipment Co. · Jan 2001
SENSAIRE DIAGNOSTIC SPIROMETER
K001278 · Qrs Diagnostic, LLC · 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
SPIROVIT SP-2, PNEUMOCHECK II
K992823 · Schiller AG · May 2000
K002499 · BRENTWOOD IQMARK DIGITAL SPIROMETER (INCLUDES DISPOSABLE PNEUMOTACH MOUTHPIECES AND 3-LITER CALIBRATION SYRINGE
Download PDF FDA Summary Brentwood Medical Tec…