Cleared Abbreviated

K001528 - PC FLOW + (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K001528 · Spirometrics Medical Equipment Co. · Anesthesiology device
Download Printable Device Report (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.

View all Spirometrics Medical Equipment Co. devices

Submission Details

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
Regulatory Context
Review time vs. panel average
107d slower than avg
Panel avg: 139d · This submission: 246d
Pathway characteristics
Standards-based clearance path.

Device Classification

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 227
Devices cleared under the same product code (BZG) and FDA review panel - the closest regulatory comparables to K001528.
MESI mTABLET SPIRO
K251777 · Mesi D.O.O. · Mar 2026
TD-7301 Spirometer (TD-7301)
K241843 · Gostar Co., Ltd. · Nov 2024
Air Next (NVD-02)
K231416 · Nuvoair AB · Jan 2024
Spirobank Oxi
K230501 · Mir Medical International Research USA · Dec 2023
EasyOne Sky Spirometer
K230178 · Ndd Medizintechnik AG · Oct 2023
Alveoair Digital Spirometer
K222525 · Roundworks Technologies Private Limited · Aug 2023