Cleared Special

K022103 - PURITAN-BENNETT 700 RENAISSANCE II SPIR...

K022103 is an FDA 510(k) clearance for PURITAN-BENNETT 700 RENAISSANCE II SPIR..., manufactured by Puritan Bennett Corp.. The device is a Class 2 Anesthesiology device with product code BZG cleared through the Special 510(k) pathway after a 91-day FDA review.

K022103 · Puritan Bennett Corp. · Anesthesiology device
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Optimized for regulatory review, auditing and printing
Sep 2002
Decision
91d
Days
Class 2
Risk

K022103 is an FDA 510(k) clearance for the PURITAN-BENNETT 700 RENAISSANCE II SPIROMETRY SYSTEM. Classified as Spirometer, Diagnostic (product code BZG), Class II - Special Controls.

Submitted by Puritan Bennett Corp. (Carlsbad, US). The FDA issued a Cleared decision on September 27, 2002 after a review of 91 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1840 - the FDA anesthesiology and respiratory device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Puritan Bennett Corp. devices

FDA 510(k) Submission Details - K022103

510(k) Number K022103 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 2002
Decision Date September 27, 2002
Days to Decision 91 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 140d · This submission: 91d
Pathway characteristics
Modification to existing cleared device.

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 49
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