510(k) · Cleared
ClearedSafety Subcutaneous Tissue Infusion Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Multi Med · FPA Set, Administration, Intravascular
Cleared on Jul 6, 2012 as substantially equivalent to K082818 (Marcal Medical, Inc., 2008) after a 165-day review. Its family tree reaches back 4 generations to 1983.
- Decided
- Jul 6, 2012
- Review
- 165 days
- Class
- Class II
- Product code
- FPA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K831445 (1983). 6 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 deviceK120195 Safety Subcutaneous Tissue Infusion SetMulti Med · 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) | K120195 | Safety Subcutaneous Tissue Infusion Set | Multi Med | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1989 | 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? (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 |
|---|---|---|---|
| * | K082818 | Subcutaneous Needle Infusion SetSummary page 2…0195 Supplement 1 21 of 22 Predicate Device: Marcal Medical, Inc. K082818 Substantial Equivalence: The Safety Subcutaneous Tissue Infusion Set is… | 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)
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 29 years and passes through 5 companies; a new generation was cleared every 6.7 years on median.
- None of the 6 ancestors has a recall.
- 3 other devices also cite its predicate K082818.
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 Safety Subcutaneous Infusion Set is designed specifically for the delivery of mnedications to the subcutaneous tissue.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120195 · printed Nov 4, 2026
Cite this page
510(k) Report. “K120195: Safety Subcutaneous Tissue Infusion Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K120195
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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