510(k) · Cleared
ClearedSCIg60 Infuser, Infuset
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 May 14, 2015 as substantially equivalent to K140131 (Emed Technologies Corporation, 2014) and 2 other predicates after a 267-day review. Its family tree reaches back 4 generations to 1983. 6 later devices descend from it.
- Decided
- May 14, 2015
- Review
- 267 days
- Class
- Class II
- Product code
- PKP
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K831445 (1983). 7 ancestors in all. 6 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK831445 Infusion Sets #'S 124 & 142 PersonalPacesetter Systems · 1983
- 3 generations backK961474 Polyfin Infusion Set MMT-106/MMT-107/MMT-133Medtronic Minimed · 1996
- 2 generations backK020530 Evans Sub-Q, Model MC4206Evans Medical, Inc. · 2002
- 1 generation backK140131 Sub-Q Subcutaneous Tissue Infusion SetEmed Technologies Corporation · 2014
- This deviceK142319 SCIg60 Infuser, InfusetEmed Technologies Corporation · 2015
- Descendant · cites it directly · 5 of its ownK161906 SCIg60 InfuserEmed Technologies Corporation · 2016
- Descendant · 2 generations on · 3 of its ownK222087 SCIg60 Infusion SystemEmed Technologies Corporation · 2022
- Descendant · 3 generations on · 1 of its ownK240148 SCIg60 Infusion SystemEmed Technologies Corporation · 2024
- Descendant · 4 generations on · 0 of its ownK251105 Tetra (TM-20); Tetra (TM-50)Emed Technologies Corporation · 2025
- Descendant · 3 generations on · 0 of its ownK230883 VersaPump Infusion SystemEmed Technologies Corporation · 2023
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K161906SCIg60 InfuserEmed Technologies Corporation · 2016 · cites it directly5descendants
- K222087SCIg60 Infusion SystemEmed Technologies Corporation · 2022 · 2 generations on3descendants
- K240148SCIg60 Infusion SystemEmed Technologies Corporation · 2024 · 3 generations on1descendant
- K251105Tetra (TM-20); Tetra (TM-50)Emed Technologies Corporation · 2025 · 4 generations on0descendants
- K230883VersaPump Infusion SystemEmed Technologies Corporation · 2023 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K831445 | Infusion Sets #'S 124 & 142 Personal | Pacesetter Systems | 1983 | — |
| −3 | K961474 | Polyfin Infusion Set MMT-106/MMT-107/MMT-133 | Medtronic Minimed | 1996 | — |
| −2 | K020530 | Evans Sub-Q, Model MC4206 | Evans Medical, Inc. | 2002 | — |
| −1 | K140131 | Sub-Q Subcutaneous Tissue Infusion Set | Emed Technologies Corporation | 2014 | — |
| 0 (this device) | K142319 | SCIg60 Infuser, Infuset | Emed Technologies Corporation | 2015 | — |
| +1 | K161906 | SCIg60 Infuser | Emed Technologies Corporation | 2016 | — |
| +2 | K222087 | SCIg60 Infusion System | Emed Technologies Corporation | 2022 | — |
| +3 | K240148 | SCIg60 Infusion System | Emed Technologies Corporation | 2024 | — |
| +4 | K251105 | Tetra (TM-20); Tetra (TM-50) | Emed Technologies Corporation | 2025 | — |
| +3 | 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 |
|---|---|---|
| 2016 | 1 | 0 |
| 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? (3)
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 |
|---|---|---|---|
| * | K140131 | Sub-Q Subcutaneous Tissue Infusion SetSummary page 5…n Pump System do not alter the intended therapeutic effect of the SCIg60 Infusion System when used as labeled. Primary Predicate Device(s) EMED Technologies Corporation K140131, SUB-Q Patient Administration Sets K140133, InfusetTM flow control extension sets Repro-Med Systems, Inc. K933652, Freedom 60 Sy… | 2014 |
| * | K140133 | Infuset Flow Control Extension SetSummary page 5…rapeutic effect of the SCIg60 Infusion System when used as labeled. Primary Predicate Device(s) EMED Technologies Corporation K140131, SUB-Q Patient Administration Sets K140133, InfusetTM flow control extension sets Repro-Med Systems, Inc. K933652, Freedom 60 Syringe Infusion Pump System with syringe set… | 2014 |
| * | K933652 | Freedom 60 Syringe Infusion Pump System with Syringe Set & TubingSummary page 5…mary Predicate Device(s) EMED Technologies Corporation K140131, SUB-Q Patient Administration Sets K140133, InfusetTM flow control extension sets Repro-Med Systems, Inc. K933652, Freedom 60 Syringe Infusion Pump System with syringe set and tubing Device Description The EMED SCIg60 Infusion System consists… | 1994 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K161906 | SCIg60 Infuser | 2016 | 5 |
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 32 years and passes through 4 companies; a new generation was cleared every 11.9 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K161906 (Emed Technologies Corporation, 2016) has gone furthest, with 5 descendants of its own.
- 1 other device also cites its predicate K140131.
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. 2015, 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) with the BD 60 ml
syringe (model no. 309653).
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/K142319 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142319: SCIg60 Infuser, Infuset.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142319
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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