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 Dec 14, 2018 as substantially equivalent to K161906 (Emed Technologies Corporation, 2016) after a 366-day review. Its family tree reaches back 6 generations to 1983.
- Decided
- Dec 14, 2018
- Review
- 366 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. No later device cites it as a predicate yet.
- 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 deviceK173783 SCIg60 Infusion SystemEmed Technologies Corporation · 2018
View 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) | 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 |
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…lation Number: 21 CFR 880.5725 Product Code: PKP Device Class: Class II Primary Predicate Device: K161906, SCIg60 Infuser Device Description The EMED SCIg60 Infusion System consists of : • SCIg60 Infuser • fixed-rate Infuset fl… | 2016 |
| † | K123729 | Versarate Flow Rate Controler | 2012 |
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 35 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.
- 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. 2018, 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 60ml syringe (model no. 309653)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173783 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173783: SCIg60 Infusion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173783
Report an extraction error
Are you the manufacturer?
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