510(k) Report

510(k) · Cleared

Cleared

Subcutaneous Needle Infusion Set

K082818510(k) TraditionalCleared Dec 23, 200889-day reviewClass II21 CFR 880.5440

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Marcal Medical, Inc. · FPA Set, Administration, Intravascular

Cleared on Dec 23, 2008 as substantially equivalent to K020530 (Evans Medical, Inc., 2002) and 1 other predicate after an 89-day review. Its family tree reaches back 3 generations to 1983. 6 later devices descend from it.

Decided
Dec 23, 2008
Review
89 days
Class
Class II
Product code
FPA
Recalls
None
Predicates
2

Its longest line of descent runs back 3 generations to K831445 (1983). 5 ancestors in all. 6 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1989: 1 other ancestor1986: 1 other ancestor2011: 1 descendant cleared2013: 1 descendant cleared2012: 3 descendants cleared2021: 1 descendant clearedK831445 · Infusion Sets #'S 124 & 142 Personal · Pacesetter Systems · 1983K961474 · Polyfin Infusion Set MMT-106/MMT-107/MMT-133 · Medtronic Minimed · 1996K020530 · Evans Sub-Q, Model MC4206 · Evans Medical, Inc. · 200219801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor3 generations back: 1 other ancestor 1 generation forward: 4 descendants2 generations forward: 2 descendants K020530 · Evans Sub-Q, Model MC4206 · Evans Medical, Inc. · 2002K961474 · Polyfin Infusion Set MMT-106/MMT-107/MMT-133 · Medtronic Minimed · 1996K831445 · Infusion Sets #'S 124 & 142 Personal · Pacesetter Systems · 19830
  1. Root · 3 generations backK831445 Infusion Sets #'S 124 & 142 PersonalPacesetter Systems · 1983
  2. 2 generations backK961474 Polyfin Infusion Set MMT-106/MMT-107/MMT-133Medtronic Minimed · 1996
  3. 1 generation backK020530 Evans Sub-Q, Model MC4206Evans Medical, Inc. · 2002
  4. This deviceK082818 Subcutaneous Needle Infusion SetMarcal Medical, Inc. · 2008
  5. Descendant · cites it directly · 3 of its ownK102512 RMS Subcutaneous Needle SetRepro-Med Systems, Inc. · 2011
  6. Descendant · 2 generations on · 0 of its ownK202279 Insignis Subcutaneous Needle SetsInnovative Health Sciences, LLC · 2021
  7. 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
  8. Descendant · cites it directly · 0 of its ownK120195 Safety Subcutaneous Tissue Infusion SetMulti Med · 2012
  9. Descendant · 2 generations on · 0 of its ownK121092 Flowease [Subcutaneous] Infusion SetBaxter Healthcare Corp · 2012

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2011: 12012: 32013: 12021: 1
2011high 3 (2012) · low 0 (2014)2026

Most influential descendants

Showing 5 of 6 · See all
  • K102512RMS Subcutaneous Needle SetRepro-Med Systems, Inc. · 2011 · cites it directly3descendants
  • K202279Insignis Subcutaneous Needle SetsInnovative Health Sciences, LLC · 2021 · 2 generations on0descendants
  • 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
  • K120195Safety Subcutaneous Tissue Infusion SetMulti Med · 2012 · cites it directly0descendants
  • K121092Flowease [Subcutaneous] Infusion SetBaxter Healthcare Corp · 2012 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K831445Infusion Sets #'S 124 & 142 PersonalPacesetter Systems1983—
−2K961474Polyfin Infusion Set MMT-106/MMT-107/MMT-133Medtronic Minimed1996—
−1K020530Evans Sub-Q, Model MC4206Evans Medical, Inc.2002—
0 (this device)K082818Subcutaneous Needle Infusion SetMarcal Medical, Inc.2008—
+1K102512RMS Subcutaneous Needle SetRepro-Med Systems, Inc.2011—
+2K202279Insignis Subcutaneous Needle SetsInnovative Health Sciences, LLC2021—
+1K122404Model Number: RMS1-2604, RMS1-2614, RMS1-2404, RMS1-2414, RMS2-2604…Repro-Med Systems, Inc. Dba Rms Medical Products20132
+1K120195Safety Subcutaneous Tissue Infusion SetMulti Med2012—
+2K121092Flowease [Subcutaneous] Infusion SetBaxter Healthcare Corp2012—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198610
198910

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201110
201230
201310
202110
FIG. 1 — Lineage of K082818, 1983–2021Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K243841 Sparta Infusion Set for Insulinscore 13.4 · 3 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K020530Evans Sub-Q, Model MC4206
Summary page 1
…rauma, and offer an opportunity to improve compliance cost-effectively through the use of a dedicated infusion set. The device is for single use only. Predicate Device: K020530 - Evans Medical, Inc - Evans Sub-Q, Model MC4206 K89 1072 - Multi-Med, Inc - Intravascular Administration Set.…
Evans Medical, Inc.2002—
*K891072Intravascular Administration Set
Summary page 1
…t-effectively through the use of a dedicated infusion set. The device is for single use only. Predicate Device: K020530 - Evans Medical, Inc - Evans Sub-Q, Model MC4206 K89 1072 - Multi-Med, Inc - Intravascular Administration Set.…
Multi-Med, Inc.1989—

Also cleared against K020530: 5 other devices →

What descends from it? (6)

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K102512RMS Subcutaneous Needle SetRepro-Med Systems, Inc.20113
K122404Model Number: RMS1-2604, RMS1-2614, RMS1-2404, RMS1-2414, RMS2-2604, RMS2-2614…Repro-Med Systems, Inc. Dba Rms Medical Products20130
K120195Safety Subcutaneous Tissue Infusion SetMulti Med20120
K120395Neria Multi Subcutaneous Infusion SetUnomedical Devices S.A DE C.V.20120

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 25 years and passes through 4 companies; a new generation was cleared every 6.7 years on median.
  • None of the 5 ancestors has a recall.
  • Of its descendants, K102512 (Repro-Med Systems, Inc., 2011) has gone furthest, with 3 descendants of its own.
  • 5 other devices also cite its predicate K020530.

How does its category compare?

All FPA devices

FPA Set, Administration, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.

FDA decisions per year · FPA

11in 2025

2007: 162008: 182009: 102010: 232011: 122012: 212013: 132014: 222015: 172016: 122017: 172018: 42019: 72020: 102021: 132022: 142023: 142024: 72025: 112026 (partial year): 5
2007high 23 (2010) · low 4 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FPA

225in 2025

2007: 75 days median2008: 89 days median2009: 166 days median2010: 120 days median2011: 87 days median2012: 96 days median2013: 90 days median2014: 89 days median2015: 123 days median2016: 195 days median2017: 240 days median2018: 177 days median2019: 161 days median2020: 327 days median2021: 186 days median2022: 213 days median2023: 340 days median2024: 244 days median2025: 225 days median2026 (partial year): 266 days median
2007high 340 (2023) · low 75 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FPA

98in 2025

2007: 172008: 152009: 1662010: 582011: 282012: 16, 4 Class I2013: 642014: 242015: 62016: 102017: 132018: 42019: 132020: 1072021: 12022: 9, 5 Class I2023: 12, 4 Class I2024: 13, 1 Class I2025: 98, 1 Class I2026 (partial year): 10, 2 Class I
2007high 166 (2009) · low 1 (2021)2026

Class I (17 since 2007) Class II/III not classified

Adverse event reports per year · FPA

34,506in 2025

2007: 1,4992008: 1,9412009: 2,5122010: 2,5372011: 4,4072012: 4,9302013: 4,6512014: 4,6952015: 6,6252016: 8,4702017: 6,4622018: 6,5742019: 11,2272020: 9,5632021: 10,4142022: 13,3932023: 10,9162024: 47,2102025: 34,506
2007high 47,210 (2024) · low 1,499 (2007)2025

MAUDE reports naming product code FPA, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071675171,499
20081889151,941
2009101661662,512
201023120582,537
20111287284,407
2012219616 (4)4,930
20131390644,651
20142289244,695
20151712366,625
201612195108,470
201717240136,462
2018417746,574
201971611311,227
2020103271079,563
202113186110,414
2022142139 (5)13,393
20231434012 (4)10,916
2024724413 (1)47,210
20251122598 (1)34,506
2026526610 (2)—

What is it indicated for?

The Subcutaneous Infusion Set is designed specifically for the delivery of medication to the

subcutaneous tissue

Indications for use as stated in the FDA summary.

Also cleared against K020530

5 other devices cite the same predicate.

  • K140131Sub-Q Subcutaneous Tissue Infusion SetEmed Technologies Corporation · 2014
  • K122404Model Number: RMS1-2604, RMS1-2614, RMS1-2404, RMS1-2414, RMS2-2604, RMS2-2614, RMS2-2404, RMS2-2414…Repro-Med Systems, Inc. Dba Rms Medical Products · 20132 recalls
  • K121092Flowease [Subcutaneous] Infusion SetBaxter Healthcare Corp · 2012
  • K102512RMS Subcutaneous Needle SetRepro-Med Systems, Inc. · 2011
  • K042666Luth-All Sub-Q Needle SetLuth-All Medical Products, LLC · 2004

Recent decisions in FPA

The FPA category page

  • K260261Gravity Blood Sets with 200µm FilterB.Braun Medical, Inc. · 2026
  • K254123Ecomed Disposable Administration SetsEcomed Solutions, LLC · 2026
  • K261530iiSure Infusion SetDeka Research and Development · 2026
  • K252543AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF…Amsino International, Inc. · 2026
  • K251375PuraCath Firefly Needleless Connector IT (9005)Puracath Medical, Inc. · 2026

https://510kreport.com/device/K082818 · printed Nov 6, 2026

Cite this page

510(k) Report. “K082818: Subcutaneous Needle 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/K082818

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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