Cleared Special

K992743 - COLLINS CPL

K992743 is an FDA 510(k) clearance for COLLINS CPL, manufactured by Collins Medical, Inc.. The device is a Class 2 Anesthesiology device with product code BZG cleared through the Special 510(k) pathway after a 28-day FDA review.

K992743 · Collins Medical, Inc. · Anesthesiology device
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Sep 1999
Decision
28d
Days
Class 2
Risk

K992743 is an FDA 510(k) clearance for the COLLINS CPL. Classified as Spirometer, Diagnostic (product code BZG), Class II - Special Controls.

Submitted by Collins Medical, Inc. (Braintree, US). The FDA issued a Cleared decision on September 13, 1999 after a review of 28 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. 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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Collins Medical, Inc. devices

FDA 510(k) Submission Details - K992743

510(k) Number K992743 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 1999
Decision Date September 13, 1999
Days to Decision 28 days
Submission Type Special
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
112d faster than avg
Panel avg: 140d · This submission: 28d
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 76
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