Cleared Traditional

K951227 - DX1

K951227 is an FDA 510(k) clearance for DX1, manufactured by Creative Biomedics, Inc.. The device is a Class 2 Anesthesiology device with product code BZG cleared through the Traditional 510(k) pathway after a 144-day FDA review.

K951227 · Creative Biomedics, Inc. · Anesthesiology device
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Aug 1995
Decision
144d
Days
Class 2
Risk

K951227 is an FDA 510(k) clearance for the DX1. Classified as Spirometer, Diagnostic (product code BZG), Class II - Special Controls.

Submitted by Creative Biomedics, Inc. (San Clemente, US). The FDA issued a Cleared decision on August 11, 1995 after a review of 144 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. 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.

View all Creative Biomedics, Inc. devices

FDA 510(k) Submission Details - K951227

510(k) Number K951227 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 1995
Decision Date August 11, 1995
Days to Decision 144 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
4d slower than avg
Panel avg: 140d · This submission: 144d
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 77
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