Ranir, LLC: FDA clearances and approvals
Ranir, LLC has 9 FDA 510(k) clearances (first 2006, latest 2013), across 2 product codes in 1 review panel. Median 510(k) review time: 42 days. openFDA lists 2 product recalls by a recalling firm named Ranir, LLC.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 2 | 70 |
| 2013 | 1 | 42 |
| 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 |
|---|---|---|---|
| OBR | Mouthguard, Over-The-Counter | 7 | 7 |
| LRK | Device, Anti-Snoring | 2 | 2 |
Review panels
- Dental (9)
Most recent Ranir, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K133423 | REST ASSURED EXTRA COMFORT NITE PROTECTOR | OBR | 2013-12-20 | 42 |
| K120103 | REST ASSURED GENERATION III DENTAL PROTECTOR | OBR | 2012-02-03 | 22 |
| K112879 | REST ASSURED READY TO WEAR NITE PROTECTOR | OBR | 2012-01-27 | 119 |
| K103004 | SNORE GUARD | LRK | 2011-02-25 | 140 |
| K102118 | SNORE GUARD ADVANCE | LRK | 2010-09-08 | 42 |
| K094020 | GRIND NO MORE GENERATION II | OBR | 2010-01-25 | 27 |
| K091792 | REST ASSURED GENERATION II DENTAL PROTECTOR | OBR | 2009-07-08 | 21 |
| K091175 | GRIND NO MORE VERSION 2 AND 3 | OBR | 2009-05-08 | 16 |
| K063229 | REST ASSURED NITE PROTECTOR | OBR | 2006-12-19 | 55 |
Recalls
2 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2013-12-18.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Ranir, LLC have?
Ranir, LLC has 9 FDA 510(k) clearances (first 2006, latest 2013), across 2 product codes in 1 review panel.
How long does FDA take to clear Ranir, LLC's 510(k)s?
The median time from FDA receipt to decision across Ranir, LLC's cleared 510(k)s is 42 days.
What devices does Ranir, LLC make?
Its most frequent FDA product codes are OBR (Mouthguard, Over-The-Counter, 7); LRK (Device, Anti-Snoring, 2).
Has Ranir, LLC had device recalls?
openFDA lists 2 product recalls in 1 recall event by a recalling firm whose name matches Ranir, LLC; the most recent began 2013-12-18. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 9 Ranir, LLC clearances with predicates and recalls
- Run predicate analysis for product code OBR, Ranir, LLC's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.