Cleared Traditional

K121161 - EMPTY EVA SOLUTION CONTAINER EMPTY EVA DUAL CHAMBER SOLUTION CONTAINER

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
Combination Product No
PCCP Authorized No
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 57
Devices cleared under the same product code (KPE) and FDA review panel - the closest regulatory comparables to K121161.
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ADDITIVE CAP
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