Cleared Traditional

K010761 - SPL-50 SPIROLYSER

K010761 is an FDA 510(k) clearance for SPL-50 SPIROLYSER, manufactured by Fim Medical. The device is a Class 2 Anesthesiology device with product code BZG cleared through the Traditional 510(k) pathway after a 357-day FDA review.

K010761 · Fim Medical · Anesthesiology device
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Mar 2002
Decision
357d
Days
Class 2
Risk

K010761 is an FDA 510(k) clearance for the SPL-50 SPIROLYSER. Classified as Spirometer, Diagnostic (product code BZG), Class II - Special Controls.

Submitted by Fim Medical (Lyon, FR). The FDA issued a Cleared decision on March 5, 2002 after a review of 357 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.

FDA 510(k) Submission Details - K010761

510(k) Number K010761 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 2001
Decision Date March 05, 2002
Days to Decision 357 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
217d slower than avg
Panel avg: 140d · This submission: 357d
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 K010761.
PULMOLAB EX671 EXERCISE TESTING SYSTEM
K020280 · Morgan Medical , Ltd. · Sep 2002
CLINDATALINK VERSION 1.0 FOR SPIROMETRY
K020004 · Compleware Corp. · Jul 2002
EMS PULMONARY FUNCTION TESTING FILTER
K013123 · Engineered Medical Systems · Mar 2002
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