Riverain Medical Group,Llc: FDA filings under this applicant name
FDA lists 3 510(k) clearances under the applicant name “Riverain Medical Group,Llc” (first 2007, latest 2011), plus 1 PMA decision, across 2 product codes in 1 review panel. Median 510(k) review time under this name: 188 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 |
|---|---|---|---|
| LLZ | System, Image Processing, Radiological | 3 | 3 |
| MYN | Analyzer, Medical Image | 1 | 0 |
Review panels
- Radiology (4)
Most recent Riverain Medical Group,Llc 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K111776 | DELTAVIEW MODEL 2.1 | LLZ | 2011-12-28 | 188 |
| K092363 | SOFTVIEW, MODEL 2.01 | LLZ | 2010-03-18 | 225 |
| K071492 | FIRSTVIEW | LLZ | 2007-08-28 | 90 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P000041 | PMA | RAPIDSCREEN RS-2000 | 2001-07-12 |
Recalls
2 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2006-05-04.
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.
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.
- Riverain Technologies, Inc. (5 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Riverain Medical Group,Llc?
FDA lists 3 510(k) clearances under the applicant name “Riverain Medical Group,Llc” (first 2007, latest 2011), plus 1 PMA decision, across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Riverain Medical Group,Llc?
The median time from FDA receipt to decision across 510(k)s cleared under the name Riverain Medical Group,Llc is 188 days.
Which FDA product codes appear under Riverain Medical Group,Llc?
The most frequent FDA product codes under this applicant name are LLZ (System, Image Processing, Radiological, 3); MYN (Analyzer, Medical Image, 1).
Next steps
- See all 3 Riverain Medical Group,Llc clearances with predicates and recalls
- Run predicate analysis for product code LLZ, Riverain Medical Group,Llc'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.