Cleared Traditional

K950223 - DISCOVERY GRAPHIC PORTABLE SPIROMETER (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K950223 · Futuremed America, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1995
Decision
311d
Days
Class 2
Risk

K950223 is an FDA 510(k) clearance for the DISCOVERY GRAPHIC PORTABLE SPIROMETER. Classified as Spirometer, Diagnostic (product code BZG), Class II - Special Controls.

Submitted by Futuremed America, Inc. (Deerpark, US). The FDA issued a Cleared decision on November 17, 1995 after a review of 311 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Futuremed America, Inc. devices

Submission Details

510(k) Number K950223 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 10, 1995
Decision Date November 17, 1995
Days to Decision 311 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
172d slower than avg
Panel avg: 139d · This submission: 311d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K950223.
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