Cleared Traditional

K983909 - MIR SPIROBANK SPIROMETER

K983909 is an FDA 510(k) clearance for MIR SPIROBANK SPIROMETER, manufactured by Mir Medical Intl. Research Srl. The device is a Class 2 Anesthesiology device with product code BZG cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K983909 · Mir Medical Intl. Research Srl · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1998
Decision
48d
Days
Class 2
Risk

K983909 is an FDA 510(k) clearance for the MIR SPIROBANK SPIROMETER. Classified as Spirometer, Diagnostic (product code BZG), Class II - Special Controls.

Submitted by Mir Medical Intl. Research Srl (Albano Laziale, Roma, IT). The FDA issued a Cleared decision on December 21, 1998 after a review of 48 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 - K983909

510(k) Number K983909 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 03, 1998
Decision Date December 21, 1998
Days to Decision 48 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 140d · This submission: 48d
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 158
Devices cleared under the same product code (BZG) and FDA review panel - the closest regulatory comparables to K983909.
SPIROVIT SP-2, PNEUMOCHECK II
K992823 · Schiller AG · May 2000
COLLINS CPL
K992743 · Collins Medical, Inc. · Sep 1999
SPIROVIT, MODEL SP-250
K984031 · Schiller AG · Apr 1999
CAIRD TECHNOLOGY SPIROMETER
K971336 · Caird Technology · Dec 1998
FLOWMATE II PLUS, MODEL #4000
K982956 · Spirometrics Medical Equipment Co. · Nov 1998
SPIROCARD
K973138 · Qrs Diagnostic, LLC · Oct 1998