Cleared Abbreviated

K001528 - PC FLOW +

K001528 is an FDA 510(k) clearance for PC FLOW +, manufactured by Spirometrics Medical Equipment Co.. The device is a Class 2 Anesthesiology device with product code BZG cleared through the Abbreviated 510(k) pathway after a 246-day FDA review.

K001528 · Spirometrics Medical Equipment Co. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2001
Decision
246d
Days
Class 2
Risk

K001528 is an FDA 510(k) clearance for the PC FLOW +. Classified as Spirometer, Diagnostic (product code BZG), Class II - Special Controls.

Submitted by Spirometrics Medical Equipment Co. (North Attleboro, US). The FDA issued a Cleared decision on January 18, 2001 after a review of 246 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

FDA 510(k) Submission Details - K001528

510(k) Number K001528 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 17, 2000
Decision Date January 18, 2001
Days to Decision 246 days
Submission Type Abbreviated
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
106d slower than avg
Panel avg: 140d · This submission: 246d
Pathway characteristics
Standards-based clearance path.

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 196
Devices cleared under the same product code (BZG) and FDA review panel - the closest regulatory comparables to K001528.
SPIROLAB II, MODEL 29
K013812 · Sdi Diagnostics, Inc. · Feb 2002
COMPAS AS (COMPUTERIZED PULMONARY ANALYSIS SYSTEM)
K013752 · Morgan Scientific, Inc. · Jan 2002
SDI SB OFFICE, MODEL 29-
K011470 · Sdi Diagnostics, Inc. · Oct 2001
SENSAIRE DIAGNOSTIC SPIROMETER
K001278 · Qrs Diagnostic, LLC · Nov 2000
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
K001528 · PC FLOW +
Download PDF FDA Summary Spirometrics Medical …