Cleared Traditional

BORA UP 2080, BORA UP 2080 OP AND BORA UP 2080 MOUNTING (K092903) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K092903 · Maquet GmbH and Co. KG · General & Plastic Surgery device
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Dec 2009
Decision
71d
Days
Class 2
Risk

K092903 is an FDA 510(k) clearance for the BORA UP 2080, BORA UP 2080 OP AND BORA UP 2080 MOUNTING. Classified as Pump, Portable, Aspiration (manual Or Powered) (product code BTA), Class II - Special Controls.

Submitted by Maquet GmbH and Co. KG (Rastatt De-Bw, DE). The FDA issued a Cleared decision on December 1, 2009 after a review of 71 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4780 - 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 Maquet GmbH and Co. KG devices

Submission Details

510(k) Number K092903 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 2009
Decision Date December 01, 2009
Days to Decision 71 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 115d · This submission: 71d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

Product Code BTA Pump, Portable, Aspiration (manual Or Powered)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4780
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 - BTA Pump, Portable, Aspiration (manual Or Powered)

All 158
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