510(k) · Cleared
ClearedSCIg60 Infuser
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 1, 2016 as substantially equivalent to K142319 (Emed Technologies Corporation, 2015) after a 142-day review. Its family tree reaches back 5 generations to 1983. 5 later devices descend from it.
- Decided
- Dec 1, 2016
- Review
- 142 days
- Class
- Class II
- Product code
- PKP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K831445 (1983). 8 ancestors in all. 5 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK831445 Infusion Sets #'S 124 & 142 PersonalPacesetter Systems · 1983
- 4 generations backK961474 Polyfin Infusion Set MMT-106/MMT-107/MMT-133Medtronic Minimed · 1996
- 3 generations backK020530 Evans Sub-Q, Model MC4206Evans Medical, Inc. · 2002
- 2 generations backK140131 Sub-Q Subcutaneous Tissue Infusion SetEmed Technologies Corporation · 2014
- 1 generation backK142319 SCIg60 Infuser, InfusetEmed Technologies Corporation · 2015
- This deviceK161906 SCIg60 InfuserEmed Technologies Corporation · 2016
- Descendant · cites it directly · 3 of its ownK222087 SCIg60 Infusion SystemEmed Technologies Corporation · 2022
- Descendant · 2 generations on · 1 of its ownK240148 SCIg60 Infusion SystemEmed Technologies Corporation · 2024
- Descendant · 3 generations on · 0 of its ownK251105 Tetra (TM-20); Tetra (TM-50)Emed Technologies Corporation · 2025
- Descendant · 2 generations on · 0 of its ownK230883 VersaPump Infusion SystemEmed Technologies Corporation · 2023
- Descendant · cites it directly · 0 of its ownK173783 SCIg60 Infusion SystemEmed Technologies Corporation · 2018
Most influential descendants
Showing 5 of 5 · See all- K222087SCIg60 Infusion SystemEmed Technologies Corporation · 2022 · cites it directly3descendants
- K240148SCIg60 Infusion SystemEmed Technologies Corporation · 2024 · 2 generations on1descendant
- K251105Tetra (TM-20); Tetra (TM-50)Emed Technologies Corporation · 2025 · 3 generations on0descendants
- K230883VersaPump Infusion SystemEmed Technologies Corporation · 2023 · 2 generations on0descendants
- K173783SCIg60 Infusion SystemEmed Technologies Corporation · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K831445 | Infusion Sets #'S 124 & 142 Personal | Pacesetter Systems | 1983 | — |
| −4 | K961474 | Polyfin Infusion Set MMT-106/MMT-107/MMT-133 | Medtronic Minimed | 1996 | — |
| −3 | K020530 | Evans Sub-Q, Model MC4206 | Evans Medical, Inc. | 2002 | — |
| −2 | K140131 | Sub-Q Subcutaneous Tissue Infusion Set | Emed Technologies Corporation | 2014 | — |
| −1 | K142319 | SCIg60 Infuser, Infuset | Emed Technologies Corporation | 2015 | — |
| 0 (this device) | K161906 | SCIg60 Infuser | Emed Technologies Corporation | 2016 | — |
| +1 | K222087 | SCIg60 Infusion System | Emed Technologies Corporation | 2022 | — |
| +2 | K240148 | SCIg60 Infusion System | Emed Technologies Corporation | 2024 | — |
| +3 | K251105 | Tetra (TM-20); Tetra (TM-50) | Emed Technologies Corporation | 2025 | — |
| +2 | K230883 | VersaPump Infusion System | Emed Technologies Corporation | 2023 | — |
| +1 | K173783 | SCIg60 Infusion System | Emed Technologies Corporation | 2018 | — |
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 |
|---|---|---|
| 2018 | 1 | 0 |
| 2022 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K142319 | SCIg60 Infuser, InfusetSummary page 4…: 916.932.0071 Fax: 916.932.0074 General This 510k submission for premarket clearance of the SCIg60 Infusion System is intended to expand the indications for use of the K142319 predicate to include infusion of the following human plasma- derived immunoglobulin solutions: - Gammagard Liquid, Immune… | 2015 |
What descends from it? (5)
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 33 years and passes through 4 companies; a new generation was cleared every 6.0 years on median.
- 1 of the 8 ancestors has a recall of any class.
- Of its descendants, K222087 (Emed Technologies Corporation, 2022) has gone furthest, with 3 descendants of its own.
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. 2016, 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 use in the home or hospital environment for the subcutaneous infusion of Hizentra, Immune Globulin Subcutaneous (Human), 20% Liquid (manufactured by CSL Behring), Gammagard Liquid, Immune Globulin Infusion (Human) 10% (manufactured by Baxalta), and Cuvitru Immune Globulin Infusion (Human) 20% (manufactured by Baxalta) with the BD 60 ml syringe (model no. 309653).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161906 · printed Nov 5, 2026
Cite this page
510(k) Report. “K161906: SCIg60 Infuser.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K161906
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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