Cleared Traditional

K251105 - Tetra (TM-20)

Also marketed or referenced as:
Tetra (TM-50)

K251105 is an FDA 510(k) clearance for Tetra (TM-20), manufactured by Emed Technologies Corporation. The device is a Class 2 General Hospital device with product code PKP cleared through the Traditional 510(k) pathway after a 255-day FDA review.

K251105 · Emed Technologies Corporation · General Hospital
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Dec 2025
Decision
255d
Days
Class 2
Risk

K251105 is an FDA 510(k) clearance for the Tetra (TM-20). Classified as Immunoglobulin G (igg) Infusion System (product code PKP), Class II - Special Controls.

Submitted by Emed Technologies Corporation (El Dorado Hills, US). The FDA issued a Cleared decision on December 22, 2025 after a review of 255 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5725 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Emed Technologies Corporation devices

FDA 510(k) Submission Details - K251105

510(k) Number K251105 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 2025
Decision Date December 22, 2025
Days to Decision 255 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
126d slower than avg
Panel avg: 129d · This submission: 255d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

PKP Device Classification - Class 2, Special Controls

Product Code PKP Immunoglobulin G (igg) Infusion System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5725
Definition An Immunoglobulin G (igg) Infusion System Is A Prescription Device Intended For Subcutaneous Delivery Of Immunoglobulin G (igg) In Accordance With The Fda Approved Labeling.
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.