River Medical, Inc.: FDA filings under this applicant name
FDA lists 16 510(k) clearances under the applicant name “River Medical, Inc.” (first 1991, latest 2003), across 8 product codes in 3 review panels. Median 510(k) review time under this name: 162 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 |
|---|---|---|---|
| ETB | Prosthesis, Partial Ossicular Replacement | 4 | 4 |
| FRN | Pump, Infusion | 4 | 4 |
| ETD | Tube, Tympanostomy | 3 | 3 |
| EQH | Source, Carrier, Fiberoptic Light | 1 | 1 |
| ETA | Replacement, Ossicular Prosthesis, Total | 1 | 1 |
| FMF | Syringe, Piston | 1 | 1 |
| FPA | Set, Administration, Intravascular | 1 | 1 |
| LDF | Electrode, Pacemaker, Temporary | 1 | 1 |
Review panels
Most recent River Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K023174 | DISPOSABLE TEMPORARY PACING WIRE | LDF | 2003-06-11 | 261 |
| K944352 | SMARTDOSE III INFUSION CONTAINER | FRN | 1995-11-15 | 435 |
| K944351 | SMARTDOSE IV PREFILLED INFUSION CONTAINER | FRN | 1995-11-15 | 435 |
| K945298 | SMARTFLOW I ADMINISTRATION SET | FPA | 1995-06-14 | 226 |
| K943692 | SMART DOSE(TM) | FRN | 1995-04-28 | 274 |
| K932895 | RIVER PUMP | FRN | 1994-03-31 | 290 |
| K933335 | RIVER VIAL ADAPTER | FMF | 1994-03-01 | 236 |
| K915120 | TEF/PLATINUM PISTON | ETB | 1991-12-27 | 44 |
| K915121 | TEF/WIRE PISTON | ETB | 1991-12-23 | 40 |
| K913287 | H/A PARTIAL - REGULAR & H/A PARTIAL - OFFSET | ETB | 1991-12-18 | 147 |
6 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named River Medical, Inc..
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 River Medical, 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.
- River'S Edge Pharmaceuticals, LLC (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under River Medical, Inc.?
FDA lists 16 510(k) clearances under the applicant name “River Medical, Inc.” (first 1991, latest 2003), across 8 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 River Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name River Medical, Inc. is 162 days.
Which FDA product codes appear under River Medical, Inc.?
The most frequent FDA product codes under this applicant name are ETB (Prosthesis, Partial Ossicular Replacement, 4); FRN (Pump, Infusion, 4); ETD (Tube, Tympanostomy, 3).
Next steps
- See all 16 River Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code ETB, River Medical, 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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.