# K122404: Model Number: RMS1-2604, RMS1-2614, RMS1-2404, RMS1-2414, RMS2-2604, RMS2-2614, RMS2-2404, RMS2-2414, RMS3-2604, RMS3-26

- Pathway: 510(k) (Traditional)
- Applicant: Repro-Med Systems, Inc. Dba Rms Medical Products
- Decided: May 6, 2013 after 272 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K831445 (1983). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102512: RMS Subcutaneous Needle Set, Repro-Med Systems, Inc. (2011) Summary page 2.
- K020530: Evans Sub-Q, Model MC4206, Evans Medical, Inc. (2002) Summary page 2.
- K082818: Subcutaneous Needle Infusion Set, Marcal Medical, Inc. (2008) Summary page 2.

## Recalls of this device
- Aug 20, 2019 · Class II · Z-0051-2020: Mislabeled needle lengths
- Mar 10, 2016 · Class II · Z-0318-2018: On 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 sup

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

Source page: https://510kreport.com/device/K122404
Methodology: https://510kreport.com/methodology