Cleared Traditional

K011470 - SDI SB OFFICE, MODEL 29-

K011470 is an FDA 510(k) clearance for SDI SB OFFICE, manufactured by Sdi Diagnostics, Inc.. The device is a Class 2 Anesthesiology device with product code BZG cleared through the Traditional 510(k) pathway after a 151-day FDA review.

K011470 · Sdi Diagnostics, Inc. · Anesthesiology device
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Oct 2001
Decision
151d
Days
Class 2
Risk

K011470 is an FDA 510(k) clearance for the SDI SB OFFICE, MODEL 29-. Classified as Spirometer, Diagnostic (product code BZG), Class II - Special Controls.

Submitted by Sdi Diagnostics, Inc. (Easton, US). The FDA issued a Cleared decision on October 12, 2001 after a review of 151 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 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. Standard predicate reliance. 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 - K011470

510(k) Number K011470 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 2001
Decision Date October 12, 2001
Days to Decision 151 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
11d slower than avg
Panel avg: 140d · This submission: 151d
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 K011470.
SPL-50 SPIROLYSER
K010761 · Fim Medical · Mar 2002
SPIROLAB II, MODEL 29
K013812 · Sdi Diagnostics, Inc. · Feb 2002
COMPAS AS (COMPUTERIZED PULMONARY ANALYSIS SYSTEM)
K013752 · Morgan Scientific, Inc. · Jan 2002
PC FLOW +
K001528 · Spirometrics Medical Equipment Co. · Jan 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