Repro-Med Systems, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Repro-Med Systems, Inc.” (first 1985, latest 2011), plus 1 PMA decision, across 5 product codes in 3 review panels. Median 510(k) review time under this name: 106 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| BSY | Catheters, Suction, Tracheobronchial | 2 | 2 |
| FRN | Pump, Infusion | 2 | 2 |
| FPA | Set, Administration, Intravascular | 1 | 1 |
| LKY | Device, External Penile Rigidity | 1 | 1 |
| LOA | Device, Testicular Hypothermia | 1 | 0 |
Review panels
Most recent Repro-Med Systems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K102512 | RMS SUBCUTANEOUS NEEDLE SET | FPA | 2011-05-20 | 261 |
| K981506 | RESTORE VACUUM ERECTION DEVICE, CONFIDE VACUUM ERECTION DEVICE, PEP (PENILE ERECTION PROGRAM), RELY VACUUM ERECTION DEV) | LKY | 1998-06-25 | 59 |
| K933652 | FREEDOM 60 SYRINGE INFUSION PUMP SYSTEM WITH SYRINGE SET & TUBING | FRN | 1994-05-18 | 294 |
| K894299 | REPRO-MED EMERGENCY AIRWAY VACUUM SYSTEM | BSY | 1989-09-22 | 92 |
| K892529 | REPRO-MED NEONATE ASPIRATION SYSTEM | BSY | 1989-06-12 | 62 |
| K844401 | REPRO-MED SYSTEMS INFUSION DEVICE | FRN | 1985-03-12 | 119 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P820034 | PMA | REPRO-MED - THD | 1984-12-26 |
Recalls
3 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2019-08-20.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Repro-Med Systems, Inc. (a text match, not an official crosswalk):
- A4220 — Refill kit for implantable infusion pump (via FRN)
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via FRN)
- E0785 — Implantable intraspinal (epidural/intrathecal) catheter used with implantable infusion pump, replacement (via FRN)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Repro-Med Systems, Inc. Dba Rms Medical Products (3 510(k)s)
- Repro-Medical System, Inc., Dba Koru Medical Systems (2 510(k)s)
- Repro-Med Systems, Inc. Dba Koru Medical Systems (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Repro-Med Systems, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Repro-Med Systems, Inc.” (first 1985, latest 2011), plus 1 PMA decision, across 5 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Repro-Med Systems, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Repro-Med Systems, Inc. is 106 days.
Which FDA product codes appear under Repro-Med Systems, Inc.?
The most frequent FDA product codes under this applicant name are BSY (Catheters, Suction, Tracheobronchial, 2); FRN (Pump, Infusion, 2); FPA (Set, Administration, Intravascular, 1).
Next steps
- See all 6 Repro-Med Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code BSY, Repro-Med Systems, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.