Rnk Products, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under 2 spellings of the applicant name “Rnk Products, Inc.” (first 2004, latest 2013), across 1 product code in 1 review panel. Median 510(k) review time under this name: 71 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 | 2 | 64 |
| 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 |
|---|---|---|---|
| DQD | Stethoscope, Electronic | 6 | 6 |
Review panels
- Cardiovascular (6)
Most recent Rnk Products, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K132560 | PCP-USB STETHOSCOPE | DQD | 2013-10-11 | 57 |
| K132405 | PPA/BT-RB STETHOSCOPE | DQD | 2013-10-11 | 70 |
| K102893 | PCP/PC STETHOSCOPE | DQD | 2011-01-20 | 112 |
| K081032 | TR-USB TELEPHONIC STETHOSCOPE | DQD | 2008-06-06 | 56 |
| K072026 | RNK ELECTRONIC STETHOSCOPE | DQD | 2007-10-26 | 94 |
| K034046 | RNK TELEPHONIC STETHOSCOPE, MODEL TR-1 | DQD | 2004-03-10 | 72 |
Recalls
openFDA lists no recalls under a recalling firm named Rnk Products, 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.
FDA spellings included
FDA records this applicant under 2 spellings (case, punctuation and legal-suffix variants of one name); this page adds them up. Filings per spelling:
- Rnk Products, Inc. (5)
- Rnk Products (1)
Frequently asked questions
How many FDA 510(k) clearances are listed under Rnk Products, Inc.?
FDA lists 6 510(k) clearances under 2 spellings of the applicant name “Rnk Products, Inc.” (first 2004, latest 2013), across 1 product code 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 Rnk Products, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Rnk Products, Inc. is 71 days.
Which FDA product codes appear under Rnk Products, Inc.?
The most frequent FDA product codes under this applicant name are DQD (Stethoscope, Electronic, 6).
Next steps
- See all 6 Rnk Products, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DQD, Rnk Products, 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.