Inovel, LLC: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Inovel, LLC” (first 2004, latest 2007), across 1 product code in 1 review panel. Median 510(k) review time under this name: 24 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 |
|---|---|---|---|
| MSH | Respirator, Surgical | 5 | 5 |
Review panels
- General Hospital (5)
Most recent Inovel, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K063747 | INOVEL HEALTH CARE N95 PARTICULATE RESPIRATORS AND SURGICAL MASKS, MODELS MFRN95-S, MFRN95-XS, MFRN95-ML, MFRN95-A | MSH | 2007-01-12 | 24 |
| K062665 | INOVEL HEALTH CARE N95 PARTICULATE RESPIRATORS AND SURGICAL MASKS | MSH | 2006-10-24 | 47 |
| K061859 | INOVEL HEALTH CARE N95 PARTICULATE RESPIRATORS & SURGICAL MASKS | MSH | 2006-07-12 | 12 |
| K051182 | INOVEL HEALTH CARE MODEL N95 PARTICULATE RESPIRATORS AND SURGICAL MASKS | MSH | 2005-05-19 | 10 |
| K042267 | INOVEL HEALTH CARE N95 PARTICULATE RESPIRATOR AND SURGICAL MASK, MODELS 3001N95-S, 3002N95-M, 3003N95-L, AND 3004N95-LP | MSH | 2004-09-30 | 38 |
Recalls
2 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2008-07-23.
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Inovel, LLC?
FDA lists 5 510(k) clearances under the applicant name “Inovel, LLC” (first 2004, latest 2007), 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 Inovel, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Inovel, LLC is 24 days.
Which FDA product codes appear under Inovel, LLC?
The most frequent FDA product codes under this applicant name are MSH (Respirator, Surgical, 5).
Next steps
- See all 5 Inovel, LLC clearances with predicates and recalls
- Run predicate analysis for product code MSH, Inovel, 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.