510(k) · Cleared
ClearedTetra (TM-20); Tetra (TM-50)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Emed Technologies Corporation · PKP Immunoglobulin G (Igg) Infusion System
Cleared on Dec 22, 2025 as substantially equivalent to K240148 (Emed Technologies Corporation, 2024) and 1 other predicate after a 255-day review. Its family tree reaches back 8 generations to 1983.
- Decided
- Dec 22, 2025
- Review
- 255 days
- Class
- Class II
- Product code
- PKP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K831445 (1983). 17 ancestors in all. No later device cites it as a predicate yet.
- Root · 8 generations backK831445 Infusion Sets #'S 124 & 142 PersonalPacesetter Systems · 1983
- 7 generations backK961474 Polyfin Infusion Set MMT-106/MMT-107/MMT-133Medtronic Minimed · 1996
- 6 generations backK020530 Evans Sub-Q, Model MC4206Evans Medical, Inc. · 2002
- 5 generations backK140131 Sub-Q Subcutaneous Tissue Infusion SetEmed Technologies Corporation · 2014
- 4 generations backK142319 SCIg60 Infuser, InfusetEmed Technologies Corporation · 2015
- 3 generations backK161906 SCIg60 InfuserEmed Technologies Corporation · 2016
- 2 generations backK222087 SCIg60 Infusion SystemEmed Technologies Corporation · 2022
- 1 generation backK240148 SCIg60 Infusion SystemEmed Technologies Corporation · 2024
- This deviceK251105 Tetra (TM-20); Tetra (TM-50)Emed Technologies Corporation · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K831445 | Infusion Sets #'S 124 & 142 Personal | Pacesetter Systems | 1983 | — |
| −7 | K961474 | Polyfin Infusion Set MMT-106/MMT-107/MMT-133 | Medtronic Minimed | 1996 | — |
| −6 | K020530 | Evans Sub-Q, Model MC4206 | Evans Medical, Inc. | 2002 | — |
| −5 | K140131 | Sub-Q Subcutaneous Tissue Infusion Set | Emed Technologies Corporation | 2014 | — |
| −4 | K142319 | SCIg60 Infuser, Infuset | Emed Technologies Corporation | 2015 | — |
| −3 | K161906 | SCIg60 Infuser | Emed Technologies Corporation | 2016 | — |
| −2 | K222087 | SCIg60 Infusion System | Emed Technologies Corporation | 2022 | — |
| −1 | K240148 | SCIg60 Infusion System | Emed Technologies Corporation | 2024 | — |
| 0 (this device) | K251105 | Tetra (TM-20); Tetra (TM-50) | Emed Technologies Corporation | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1994 | 1 | 0 |
| 1998 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2009 | 1 | 0 |
| 2014 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in PKP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new PKP device
- #1 K222087 SCIg60 Infusion Systemscore 11.7 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K240148 | SCIg60 Infusion SystemSummary page 5…: Immunoglobulin G (IgG) Infusion System Regulation Number: 880.5725 Product Code: PKP, FRN III. PREDICATE DEVICES (21 CFR 807.92(a)(3)) Primary: K240148, SCIg60 Infusion System (Product Code – PKP) Secondary: K091042, Crono S-PID 50 (Product Code – FRN) These predica… | 2024 |
| * | K091042 | Crono S-Pid 50Summary page 5…5725 Product Code: PKP, FRN III. PREDICATE DEVICES (21 CFR 807.92(a)(3)) Primary: K240148, SCIg60 Infusion System (Product Code – PKP) Secondary: K091042, Crono S-PID 50 (Product Code – FRN) These predicates have not been subject to a design-related recall. IV. DEVICE DE… | 2009 |
| † | K140131 | Sub-Q Subcutaneous Tissue Infusion Set | 2014 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 42 years and passes through 4 companies; a new generation was cleared every 5.9 years on median.
- 5 of the 17 ancestors have a recall of any class.
How does its category compare?
All PKP devicesPKP Immunoglobulin G (Igg) Infusion System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · PKP
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PKP
Too few PKP 510(k)s in any year since 2007 to give a median.
Recalls per year · PKP
No recall names PKP since 2007.
Adverse event reports per year · PKP
1in 2025
MAUDE reports naming product code PKP, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 3 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 2 |
| 2025 | 1 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The EMED Tetra Micro Infusion System is intended for subcutaneous infusion for prescription liquid medicines for use in the home and hospital environment by adults and children (2 years and older), when administered according to the approved biologic or drug product labeling. The Tetra Micro Infusion System is indicated for use with:
- Hizentra Immune Globulin Subcutaneous (Human) 20%, manufactured by CSL Behring.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251105 · printed Nov 4, 2026
Cite this page
510(k) Report. “K251105: Tetra (TM-20); Tetra (TM-50).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K251105
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026