Ino Therapeutics: FDA filings under this applicant name
FDA lists 13 510(k) clearances under the applicant name “Ino Therapeutics” (first 2005, latest 2013), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 114 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 | 2 | 118 |
| 2013 | 1 | 56 |
| 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 |
|---|---|---|---|
| MRN | Apparatus, Nitric Oxide Delivery | 10 | 10 |
| MRO | Apparatus, Nitric Oxide, Backup Delivery | 2 | 2 |
| MNR | Ventilatory Effort Recorder | 1 | 1 |
Review panels
- Anesthesiology (13)
Most recent Ino Therapeutics 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K130605 | INOMAX DSIR (DELIVERY SYSTEM) | MRN | 2013-05-02 | 56 |
| K122689 | INOBLENDER | MRO | 2012-11-07 | 64 |
| K121021 | INOMAX DS (DELIVERY SYSTEM) | MRN | 2012-09-24 | 173 |
| K110344 | INOMAX DSIR (DELIVERY SYSTEM) | MRN | 2011-06-24 | 140 |
| K093922 | INOMAX DS | MRN | 2010-04-15 | 114 |
| K092545 | INOMAX DS (DELIVERY SYSTEM), MODEL 10003 | MRN | 2010-03-10 | 203 |
| K090958 | INOMAX DS (DELIVERY SYSTEM) | MNR | 2009-06-18 | 73 |
| K081691 | INOMAX DS (DELIVERY SYSTEM) | MRN | 2008-08-28 | 72 |
| K080484 | INOMAX DS (DELIVERY SYSTEM), MODEL 10003 | MRN | 2008-08-06 | 166 |
| K071516 | INOMAX DS | MRN | 2007-10-03 | 121 |
3 earlier clearances. See the full list in Caduvo.
Recalls
2 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2010-11-30.
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 Ino Therapeutics?
FDA lists 13 510(k) clearances under the applicant name “Ino Therapeutics” (first 2005, latest 2013), across 3 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 Ino Therapeutics?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ino Therapeutics is 114 days.
Which FDA product codes appear under Ino Therapeutics?
The most frequent FDA product codes under this applicant name are MRN (Apparatus, Nitric Oxide Delivery, 10); MRO (Apparatus, Nitric Oxide, Backup Delivery, 2); MNR (Ventilatory Effort Recorder, 1).
Next steps
- See all 13 Ino Therapeutics clearances with predicates and recalls
- Run predicate analysis for product code MRN, Ino Therapeutics'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.