Cleared Traditional

K251105 - Tetra (TM-20) (FDA 510(k) Clearance)

Also includes:
Tetra (TM-50)

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

K251105 · Emed Technologies Corporation · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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
127d slower than avg
Panel avg: 128d · This submission: 255d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.