Cleared Traditional

K945154 - BA-CPAS

K945154 is an FDA 510(k) clearance for BA-CPAS, manufactured by Nobelpharma USA, Inc.. The device is a Class 2 General & Plastic Surgery device with product code FZE cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K945154 · Nobelpharma USA, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1995
Decision
84d
Days
Class 2
Risk

K945154 is an FDA 510(k) clearance for the BA-CPAS. Classified as Prosthesis, Nose, Internal (product code FZE), Class II - Special Controls.

Submitted by Nobelpharma USA, Inc. (Westmont, US). The FDA issued a Cleared decision on January 13, 1995 after a review of 84 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.3680 - the FDA general and plastic surgery 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Nobelpharma USA, Inc. devices

FDA 510(k) Submission Details - K945154

510(k) Number K945154 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 1994
Decision Date January 13, 1995
Days to Decision 84 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
31d faster than avg
Panel avg: 115d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FZE Device Classification - Class 2, Special Controls

Product Code FZE Prosthesis, Nose, Internal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.3680
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 General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - FZE Prosthesis, Nose, Internal

All 25
Devices cleared under the same product code (FZE) and FDA review panel - the closest regulatory comparables to K945154.
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NASAL DORSUM
K925743 · Smith & Nephew Richards, Inc. · Aug 1993