510(k) Report

510(k) · Cleared

Recalled · Class II · 2019

Model Number: RMS1-2604, RMS1-2614, RMS1-2404, RMS1-2414, RMS2-2604, RMS2-2614, RMS2-2404, RMS2-2414, RMS3-2604, RMS3-26

K122404510(k) TraditionalCleared May 6, 2013272-day reviewClass II21 CFR 880.5440Recalls 2

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

Repro-Med Systems, Inc. Dba Rms Medical Products · FPA Set, Administration, Intravascular

Cleared on May 6, 2013 as substantially equivalent to K102512 (Repro-Med Systems, Inc., 2011) and 2 other predicates after a 272-day review. Its family tree reaches back 5 generations to 1983. It has been recalled 2 times.

Decided
May 6, 2013
Review
272 days
Class
Class II
Product code
FPA
Recalls
2
Predicates
3

Its longest line of descent runs back 5 generations to K831445 (1983). 7 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1989: 1 other ancestor1986: 1 other ancestorK831445 · 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. · 2002K082818 · Subcutaneous Needle Infusion Set · Marcal Medical, Inc. · 2008K102512 · RMS Subcutaneous Needle Set · Repro-Med Systems, Inc. · 201119801985199019952000200520102015
Other ancestors, by generation 2 generations back: 1 other ancestor3 generations back: 1 other ancestor K102512 · RMS Subcutaneous Needle Set · Repro-Med Systems, Inc. · 2011K082818 · Subcutaneous Needle Infusion Set · Marcal Medical, Inc. · 2008K020530 · 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 · 1983−50
  1. Root · 5 generations backK831445 Infusion Sets #'S 124 & 142 PersonalPacesetter Systems · 1983
  2. 4 generations backK961474 Polyfin Infusion Set MMT-106/MMT-107/MMT-133Medtronic Minimed · 1996
  3. 3 generations backK020530 Evans Sub-Q, Model MC4206Evans Medical, Inc. · 2002
  4. 2 generations backK082818 Subcutaneous Needle Infusion SetMarcal Medical, Inc. · 2008
  5. 1 generation backK102512 RMS Subcutaneous Needle SetRepro-Med Systems, Inc. · 2011
  6. This deviceK122404 Model Number: RMS1-2604, RMS1-2614, RMS1-2404, RMS1-2414, RMS2-2604…Repro-Med Systems, Inc. Dba Rms Medical Products · 2013
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K831445Infusion Sets #'S 124 & 142 PersonalPacesetter Systems1983—
−4K961474Polyfin Infusion Set MMT-106/MMT-107/MMT-133Medtronic Minimed1996—
−3K020530Evans Sub-Q, Model MC4206Evans Medical, Inc.2002—
−2K082818Subcutaneous Needle Infusion SetMarcal Medical, Inc.2008—
−1K102512RMS Subcutaneous Needle SetRepro-Med Systems, Inc.2011—
0 (this device)K122404Model Number: RMS1-2604, RMS1-2614, RMS1-2404, RMS1-2414, RMS2-2604…Repro-Med Systems, Inc. Dba Rms Medical Products2013—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198610
198910
FIG. 1 — Lineage of K122404, 1983–2013Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K102512RMS Subcutaneous Needle Set
Summary page 2
…------ --------.- O3RMSM 0MEDICALPRODUCTS Substantial Equivalence to Predicate Devices: RMS Medical Products Subcutaneous Needle Set K102512 Evans Medical, Inc. Evans Winged Sub-q MC4206 K020530 MarCal Medical, Inc. Subcutaneous Needle Infusion Set K…
Repro-Med Systems, Inc.2011—
*K020530Evans Sub-Q, Model MC4206
Summary page 2
…Substantial Equivalence to Predicate Devices: RMS Medical Products Subcutaneous Needle Set K102512 Evans Medical, Inc. Evans Winged Sub-q MC4206 K020530 MarCal Medical, Inc. Subcutaneous Needle Infusion Set K082818 Device Description: The RMS HIgH-Flo M Subcutaneou…
Evans Medical, Inc.2002—
*K082818Subcutaneous Needle Infusion Set
Summary page 2
…cts Subcutaneous Needle Set K102512 Evans Medical, Inc. Evans Winged Sub-q MC4206 K020530 MarCal Medical, Inc. Subcutaneous Needle Infusion Set K082818 Device Description: The RMS HIgH-Flo M Subcutaneous Safety Needle Sets are a Class 11intravascular Administration Set p…
Marcal Medical, Inc.2008—

Also cleared against K102512: 2 other devices →

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

DateClassRecallRoot causeReason
Aug 20, 2019Class IIZ-0051-2020Under Investigation by firmMislabeled needle lengths
Mar 10, 2016Class IIZ-0318-2018Nonconforming Material/ComponentOn 2/24/2016 during post sterilization inspection of part number F180 Precision Flow Rate Tubing, Lot number 1.042/16 the firm found 701 out of 3,195 were rejected due to visual defect, gap in the supplier s manufacturing seal for Part…

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 30 years and passes through 6 companies; a new generation was cleared every 6.0 years on median.
  • None of the 7 ancestors has a recall.
  • 2 other devices also cite its predicate K102512.

How does its category compare?

All FPA devices

FPA Set, Administration, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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?

RMS HIgH-Fo Tm Subcutaneous Safety Needle Sets are intended for the delivery of medication to the subcutaneous tissue.

Indications for use as stated in the FDA summary.

Also cleared against K102512

2 other devices cite the same predicate.

  • K202279Insignis Subcutaneous Needle SetsInnovative Health Sciences, LLC · 2021
  • K121092Flowease [Subcutaneous] Infusion SetBaxter Healthcare Corp · 2012

More from Repro-Med Systems, Inc. Dba Rms…

3 FDA decisions under this applicant name. See the company

  • K180843HIgH-Flo Super26 Subcutaneous Needle SetsRepro-Med Systems, Inc. Dba Rms Medical Products · 2019
  • K162613Integrated Catch-up Freedom Syringe Driver Infusion SystemRepro-Med Systems, Inc. Dba Rms Medical Products · 2017

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/K122404 · printed Nov 6, 2026

Cite this page

510(k) Report. “K122404: Model Number: RMS1-2604, RMS1-2614, RMS1-2404, RMS1-2414, RMS2-2604, RMS2-2614, RMS2-2404, RMS2-2414, RMS3-2604, RMS3-26.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122404

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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