Cleared Traditional

K122619 - EPIX IRRIGATION PUMP

K122619 is an FDA 510(k) clearance for EPIX IRRIGATION PUMP, manufactured by Applied Medical. The device is a Class 2 General & Plastic Surgery device with product code BTA cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K122619 · Applied Medical · General & Plastic Surgery device
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Oct 2012
Decision
35d
Days
Class 2
Risk

K122619 is an FDA 510(k) clearance for the EPIX IRRIGATION PUMP, EPIX SUCTION IRRIGATION TUBING SET. Classified as Pump, Portable, Aspiration (manual Or Powered) (product code BTA), Class II - Special Controls.

Submitted by Applied Medical (Rancho Santa, US). The FDA issued a Cleared decision on October 2, 2012 after a review of 35 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 Applied Medical devices

FDA 510(k) Submission Details - K122619

510(k) Number K122619 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 2012
Decision Date October 02, 2012
Days to Decision 35 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
80d faster than avg
Panel avg: 115d · This submission: 35d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BTA Device Classification - Class 2, Special Controls

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 69
Devices cleared under the same product code (BTA) and FDA review panel - the closest regulatory comparables to K122619.
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SMARTSUCTION SOLO DEVICE
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