# Repro-Med Systems, Inc.

- Location (FDA's records): Middletown, NY
- FDA decisions: 7 (1984–2011): 6 510(k) clearances and 1 original PMA approval
- Product codes: BSY (2), FRN (2), FPA (1), LKY (1), LOA (1)
- Predicates its devices cite: 5 (0 its own); citations of its devices by later devices: 8 (0 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Evans Medical, Inc.: 1 (https://510kreport.com/company/evans-medical)
- Marcal Medical, Inc.: 1 (https://510kreport.com/company/marcal-medical)
- Nu-Potent: 1 (https://510kreport.com/company/nu-potent)
- Imagyn Medical Technologies, Inc.: 1 (https://510kreport.com/company/imagyn-medical-technologies)
- Numedtec, Inc.: 1 (https://510kreport.com/company/numedtec)

## Firms that cite its devices most
- Vacurect Manufacturing (Pty), Ltd.: 2 (https://510kreport.com/company/vacurect-manufacturing)
- Repro-Med Systems, Inc. Dba Rms Medical Products: 2 (https://510kreport.com/company/repro-med-systems-dba-rms-medical-products)
- Emed Technologies Corporation: 2 (https://510kreport.com/company/emed-technologies)
- Innovative Health Sciences, LLC: 1 (https://510kreport.com/company/innovative-health-sciences)
- Baxter Healthcare Corp: 1 (https://510kreport.com/company/baxter-healthcare)

## Its most-cited devices
- K102512: RMS Subcutaneous Needle Set (2011), cited by 3
- K933652: Freedom 60 Syringe Infusion Pump System with Syringe Set & Tubing (1994), cited by 3
- K981506: Restore Vacuum Erection Device, Confide Vacuum Erection Device, Pep (Penile Erection Program), Rely Vacuum Erection Dev) (1998), cited by 2

## Recent decisions
- K102512: RMS Subcutaneous Needle Set (May 20, 2011)
- K981506: Restore Vacuum Erection Device, Confide Vacuum Erection Device, Pep (Penile Erection Program), Rely Vacuum Erection Dev) (Jun 25, 1998)
- K933652: Freedom 60 Syringe Infusion Pump System with Syringe Set & Tubing (May 18, 1994)
- K894299: Repro-Med Emergency Airway Vacuum System (Sep 22, 1989)
- K892529: Repro-Med Neonate Aspiration System (Jun 12, 1989)
- K844401: Repro-Med Systems Infusion Device (Mar 12, 1985)
- P820034: Repro-Med - THD (Dec 26, 1984)

Source page: https://510kreport.com/company/repro-med-systems