510(k) · Cleared
Recalled · Class II · 2015Neria Multi Subcutaneous Infusion Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Unomedical Devices S.A DE C.V. · FPA Set, Administration, Intravascular
Cleared on May 30, 2012 as substantially equivalent to K945617 (Pharma-Plast Intl. A/S, 1995) and 1 other predicate after a 112-day review. Its family tree reaches back 4 generations to 1983. It has been recalled once.
- Decided
- May 30, 2012
- Review
- 112 days
- Class
- Class II
- Product code
- FPA
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 4 generations to K831445 (1983). 7 ancestors in all. No later device cites it as a predicate yet.
- 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 backK082818 Subcutaneous Needle Infusion SetMarcal Medical, Inc. · 2008
- This deviceK120395 Neria Multi Subcutaneous Infusion SetUnomedical Devices S.A DE C.V. · 2012
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 | K082818 | Subcutaneous Needle Infusion Set | Marcal Medical, Inc. | 2008 | — |
| 0 (this device) | K120395 | Neria Multi Subcutaneous Infusion Set | Unomedical Devices S.A DE C.V. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1989 | 1 | 0 |
| 1995 | 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 FPA? 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 FPA device
- #1 K243841 Sparta Infusion Set for Insulinscore 13.4 · 3 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 |
|---|---|---|---|
| * | K945617 | Pharma-Plast Pureline (TM) Basic (TM) and Pureline (TM) Contact (TM) Subcutaneous…Summary page 1…0 8.6 Predicate Devices The neriam multi Subcutaneous Infusion Sets are substantially equivalent to the Unomedical Contactm Subcutaneous Infusion Sets (K945617) and the MarCal Medical Sub 0 Needle infusion set (K082818). 8.7 Indication for Use The sets are indicated for… | 1995 |
| * | K082818 | Subcutaneous Needle Infusion SetSummary page 1…Infusion Sets are substantially equivalent to the Unomedical Contactm Subcutaneous Infusion Sets (K945617) and the MarCal Medical Sub 0 Needle infusion set (K082818). 8.7 Indication for Use The sets are indicated for the infusion of fluids into the body below the surface of t… | 2008 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 21, 2015 | Class II | Z-1821-2015 | Nonconforming Material/Component | Unomedical has found that in rare cases the steel needle can break during use, interrupting the delivery of medication including insulin. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 29 years and passes through 5 companies; a new generation was cleared every 6.7 years on median.
- None of the 7 ancestors has a recall.
How does its category compare?
All FPA devicesFPA Set, Administration, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · FPA
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FPA
225in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FPA
98in 2025
Class I (17 since 2007) Class II/III not classified
Adverse event reports per year · FPA
34,506in 2025
MAUDE reports naming product code FPA, 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 | 16 | 75 | 17 | 1,499 |
| 2008 | 18 | 89 | 15 | 1,941 |
| 2009 | 10 | 166 | 166 | 2,512 |
| 2010 | 23 | 120 | 58 | 2,537 |
| 2011 | 12 | 87 | 28 | 4,407 |
| 2012 | 21 | 96 | 16 (4) | 4,930 |
| 2013 | 13 | 90 | 64 | 4,651 |
| 2014 | 22 | 89 | 24 | 4,695 |
| 2015 | 17 | 123 | 6 | 6,625 |
| 2016 | 12 | 195 | 10 | 8,470 |
| 2017 | 17 | 240 | 13 | 6,462 |
| 2018 | 4 | 177 | 4 | 6,574 |
| 2019 | 7 | 161 | 13 | 11,227 |
| 2020 | 10 | 327 | 107 | 9,563 |
| 2021 | 13 | 186 | 1 | 10,414 |
| 2022 | 14 | 213 | 9 (5) | 13,393 |
| 2023 | 14 | 340 | 12 (4) | 10,916 |
| 2024 | 7 | 244 | 13 (1) | 47,210 |
| 2025 | 11 | 225 | 98 (1) | 34,506 |
| 2026 | 5 | 266 | 10 (2) | — |
What is it indicated for?
The sets are intended for the infusion of fluids into the body below the surface of the skin when attached to a fluid reservoir.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120395 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120395: Neria Multi Subcutaneous Infusion Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120395
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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