510(k) · Cleared
ClearedSCIg60 Infusion System
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 Oct 13, 2022 as substantially equivalent to K161906 (Emed Technologies Corporation, 2016) after a 90-day review. Its family tree reaches back 6 generations to 1983. 3 later devices descend from it.
- Decided
- Oct 13, 2022
- Review
- 90 days
- Class
- Class II
- Product code
- PKP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K831445 (1983). 9 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK831445 Infusion Sets #'S 124 & 142 PersonalPacesetter Systems · 1983
- 5 generations backK961474 Polyfin Infusion Set MMT-106/MMT-107/MMT-133Medtronic Minimed · 1996
- 4 generations backK020530 Evans Sub-Q, Model MC4206Evans Medical, Inc. · 2002
- 3 generations backK140131 Sub-Q Subcutaneous Tissue Infusion SetEmed Technologies Corporation · 2014
- 2 generations backK142319 SCIg60 Infuser, InfusetEmed Technologies Corporation · 2015
- 1 generation backK161906 SCIg60 InfuserEmed Technologies Corporation · 2016
- This deviceK222087 SCIg60 Infusion SystemEmed Technologies Corporation · 2022
- Descendant · cites it directly · 1 of its ownK240148 SCIg60 Infusion SystemEmed Technologies Corporation · 2024
- Descendant · 2 generations on · 0 of its ownK251105 Tetra (TM-20); Tetra (TM-50)Emed Technologies Corporation · 2025
- Descendant · cites it directly · 0 of its ownK230883 VersaPump Infusion SystemEmed Technologies Corporation · 2023
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K831445 | Infusion Sets #'S 124 & 142 Personal | Pacesetter Systems | 1983 | — |
| −5 | K961474 | Polyfin Infusion Set MMT-106/MMT-107/MMT-133 | Medtronic Minimed | 1996 | — |
| −4 | K020530 | Evans Sub-Q, Model MC4206 | Evans Medical, Inc. | 2002 | — |
| −3 | K140131 | Sub-Q Subcutaneous Tissue Infusion Set | Emed Technologies Corporation | 2014 | — |
| −2 | K142319 | SCIg60 Infuser, Infuset | Emed Technologies Corporation | 2015 | — |
| −1 | K161906 | SCIg60 Infuser | Emed Technologies Corporation | 2016 | — |
| 0 (this device) | K222087 | SCIg60 Infusion System | Emed Technologies Corporation | 2022 | — |
| +1 | K240148 | SCIg60 Infusion System | Emed Technologies Corporation | 2024 | — |
| +2 | K251105 | Tetra (TM-20); Tetra (TM-50) | Emed Technologies Corporation | 2025 | — |
| +1 | K230883 | VersaPump Infusion System | Emed Technologies Corporation | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1994 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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 K251105 Tetra (TM-20); Tetra (TM-50)score 12.7 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K161906 | SCIg60 InfuserSummary page 4…Regulation Number: 21 CFR §880.5725 Product Code: PKP (Immunoglobulin G (IgG) infusion system) III. PREDICATE DEVICES Primary Predicate Device: K161906, SCIg60 Infusion System (Product Code – PKP) IV. DEVICE DESCRIPTION The EMED SCIg60 Infusion System consists of the SC… | 2016 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 39 years and passes through 4 companies; a new generation was cleared every 6.0 years on median.
- 1 of the 9 ancestors has a recall of any class.
- Of its descendants, K240148 (Emed Technologies Corporation, 2024) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K161906.
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. 2022, 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 SCIg60 Infusion System is intended for the subcutaneous infusion of the following immunoglobulin liquid medications: * Hizentra, Immune Globulin Subcutaneous (Human) 20% (manufactured by CSL Behring), » Gammagard Liquid, Immune Globulin Infusion (Human) 10% (manufactured by Takeda Pharmaceutical Company, formerly Baxalta), * Cuvitru Immune Globulin Infusion (Human) 20% (manufactured by Takeda Pharmaceutical Company, formerly Baxalta) * Gamunex-C…
Read the full statement (119 words)
The SCIg60 Infusion System is intended for the subcutaneous infusion of the following immunoglobulin liquid medications:
* Hizentra, Immune Globulin Subcutaneous (Human) 20% (manufactured by CSL Behring),
» Gammagard Liquid, Immune Globulin Infusion (Human) 10% (manufactured by Takeda Pharmaceutical Company, formerly Baxalta),
* Cuvitru Immune Globulin Infusion (Human) 20% (manufactured by Takeda Pharmaceutical Company, formerly Baxalta)
* Gamunex-C Immune Globulin Subcutaneous (Human), 10% (manufactured by Grifols Therapeutics, Inc.),
» Gammaked Immune Globulin Subcutaneous (Human), 10% (manufactured by Grifols Therapeutics, Inc.)
» Xembify Immune Globulin Subcutaneous (Human), 20% (manufactured by Grifols Therapeutics, Inc.), and
* Cutaquig Immune Globulin Subcutaneous (Human), 16.5% (manufactured by Octapharma AG)
with the BD 50 ml syringe (model no. 309653) in the home or hospital environment.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K222087 · printed Nov 5, 2026
Cite this page
510(k) Report. “K222087: SCIg60 Infusion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K222087
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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