Cleared Traditional

K121161 - EMPTY EVA SOLUTION CONTAINER EMPTY EVA ...

K121161 is an FDA 510(k) clearance for EMPTY EVA SOLUTION CONTAINER EMPTY EVA ..., manufactured by Acta Medical, LLC. The device is a Class 2 General Hospital device with product code KPE cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K121161 · Acta Medical, LLC · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2012
Decision
87d
Days
Class 2
Risk

K121161 is an FDA 510(k) clearance for the EMPTY EVA SOLUTION CONTAINER EMPTY EVA DUAL CHAMBER SOLUTION CONTAINER. Classified as Container, I.v. (product code KPE), Class II - Special Controls.

Submitted by Acta Medical, LLC (Plano, US). The FDA issued a Cleared decision on July 13, 2012 after a review of 87 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5025 - the FDA general hospital 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 Acta Medical, LLC devices

FDA 510(k) Submission Details - K121161

510(k) Number K121161 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 2012
Decision Date July 13, 2012
Days to Decision 87 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 129d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KPE Device Classification - Class 2, Special Controls

Product Code KPE Container, I.v.
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5025
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 Hospital devices follow this clearance model.

Regulatory Peers - KPE Container, I.v.

All 43
Devices cleared under the same product code (KPE) and FDA review panel - the closest regulatory comparables to K121161.
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