Respicardia: FDA filings under this applicant name
FDA lists 1 510(k) clearance under the applicant name “Respicardia” (first 2013, latest 2013), plus 1 PMA decision, across 2 product codes in 2 review panels. Median 510(k) review time under this name: 245 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 |
|---|---|---|
| 2013 | 1 | 245 |
| 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 |
|---|---|---|---|
| DQY | Catheter, Percutaneous | 1 | 1 |
| PSR | Implanted Phrenic Nerve Stimulator For Central Sleep Apnea | 1 | 0 |
Review panels
- Anesthesiology (1)
- Cardiovascular (1)
Most recent Respicardia 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K130378 | RESPIGUIDE DELIVERY SYSTEM | DQY | 2013-10-17 | 245 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P160039 | PMA | remede® System | 2017-10-06 |
Recalls
openFDA lists no recalls under a recalling firm named Respicardia.
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.
Device clinical trials
An industry sponsor named Respicardia is the lead sponsor of 6 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:
- NCT03985527: Janus Feasibility Study (Completed, started 2020-01-09)
- NCT03884660: remedē System Therapy Study (Active not recruiting, started 2019-06-18)
- NCT01816776: Respicardia, Inc. Pivotal Trial of the remedē System (Completed, started 2013-03)
- NCT01124370: Chronic Evaluation of Respicardia Therapy (Completed, started 2010-05)
- NCT01008670: Identification of the Pericardiophrenic Vein During Cardiac Device Implant Procedures to Prevent Extracardiac Stimulation (Completed, started 2007-12)
Frequently asked questions
How many FDA 510(k) clearances are listed under Respicardia?
FDA lists 1 510(k) clearance under the applicant name “Respicardia” (first 2013, latest 2013), plus 1 PMA decision, across 2 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Respicardia?
The median time from FDA receipt to decision across 510(k)s cleared under the name Respicardia is 245 days.
Which FDA product codes appear under Respicardia?
The most frequent FDA product codes under this applicant name are DQY (Catheter, Percutaneous, 1); PSR (Implanted Phrenic Nerve Stimulator For Central Sleep Apnea, 1).
Next steps
- See all 1 Respicardia clearances with predicates and recalls
- Run predicate analysis for product code DQY, Respicardia'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.