510(k) · Cleared
ClearedRMS Subcutaneous Needle Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Repro-Med Systems, Inc. · FPA Set, Administration, Intravascular
Cleared on May 20, 2011 as substantially equivalent to K020530 (Evans Medical, Inc., 2002) and 1 other predicate after a 261-day review. Its family tree reaches back 4 generations to 1983. 3 later devices descend from it.
- Decided
- May 20, 2011
- Review
- 261 days
- Class
- Class II
- Product code
- FPA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K831445 (1983). 6 ancestors in all. 3 later devices descend from it, 3 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 backK082818 Subcutaneous Needle Infusion SetMarcal Medical, Inc. · 2008
- This deviceK102512 RMS Subcutaneous Needle SetRepro-Med Systems, Inc. · 2011
- Descendant · cites it directly · 0 of its ownK202279 Insignis Subcutaneous Needle SetsInnovative Health Sciences, LLC · 2021
- Descendant · cites it directly · 0 of its ownK122404 Model Number: RMS1-2604, RMS1-2614, RMS1-2404, RMS1-2414, RMS2-2604…Repro-Med Systems, Inc. Dba Rms Medical Products · 2013 · Recalled
- Descendant · cites it directly · 0 of its ownK121092 Flowease [Subcutaneous] Infusion SetBaxter Healthcare Corp · 2012
Most influential descendants
Showing 3 of 3 · See all- K202279Insignis Subcutaneous Needle SetsInnovative Health Sciences, LLC · 2021 · cites it directly0descendants
- K122404Model Number: RMS1-2604, RMS1-2614, RMS1-2404, RMS1-2414, RMS2-2604, RMS2-2614…Repro-Med Systems, Inc. Dba Rms Medical Products · 2013 · cites it directly0descendants
- K121092Flowease [Subcutaneous] Infusion SetBaxter Healthcare Corp · 2012 · cites it directly0descendants
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) | K102512 | RMS Subcutaneous Needle Set | Repro-Med Systems, Inc. | 2011 | — |
| +1 | K202279 | Insignis Subcutaneous Needle Sets | Innovative Health Sciences, LLC | 2021 | — |
| +1 | K122404 | Model Number: RMS1-2604, RMS1-2614, RMS1-2404, RMS1-2414, RMS2-2604… | Repro-Med Systems, Inc. Dba Rms Medical Products | 2013 | 2 |
| +1 | K121092 | Flowease [Subcutaneous] Infusion Set | Baxter Healthcare Corp | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1989 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2021 | 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 |
|---|---|---|---|
| * | K020530 | Evans Sub-Q, Model MC4206Summary page 1…redicate Devices: Evans Medical, Inc. Evans Sub-q MC4206 K020530 Marcal Medical, Inc. Subcutaneous… | 2002 |
| * | K082818 | Subcutaneous Needle Infusion SetSummary page 1…Marcal Medical, Inc. Subcutaneous Needle Infusion Set K082818 4. Device Description: The RMS Subcutaneous Needle Set is a Class 11Intravascular Administration Set per 21 CFR… | 2008 |
What descends from it? (3)
3 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 28 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.
- Of its descendants, K202279 (Innovative Health Sciences, LLC, 2021) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K020530.
How does its category compare?
All FPA devicesFPA Set, Administration, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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?
RMS Subcutaneous Needle Sets are intended for the delivery of medication to the subcutaneous tissue.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102512 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102512: RMS Subcutaneous Needle Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102512
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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