Rebound Therapeutics: FDA filings under this applicant name
FDA lists 8 510(k) clearances under 2 spellings of the applicant name “Rebound Therapeutics” (first 2018, latest 2023), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 92 days. Since 2017 the median was 92 days, against 113 days for all cleared 510(k)s in the same product codes. 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 |
|---|---|---|
| 2018 | 1 | 56 |
| 2019 | 3 | 148 |
| 2020 | 2 | 91 |
| 2021 | 1 | 345 |
| 2022 | 0 | — |
| 2023 | 1 | 59 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Rebound Therapeutics took a median 92 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 113 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 4 | 4 |
| GWG | Endoscope, Neurological | 4 | 4 |
Review panels
Most recent Rebound Therapeutics 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K232618 | Aurora Surgiscope System | GWG | 2023-10-27 | 59 |
| K203745 | AURORA Evacuator +Coag | GEI | 2021-12-02 | 345 |
| K201840 | Aurora Surgiscope System (Surgiscope), Aurora Surgiscope System (Image Control Box) | GWG | 2020-11-04 | 125 |
| K201637 | Aurora Evacuator +Coag | GEI | 2020-08-12 | 57 |
| K191861 | Aurora Surgiscope System | GWG | 2019-12-06 | 148 |
| K190075 | Aurora Evacuator | GEI | 2019-02-12 | 27 |
| K182211 | Aurora Surgiscope System | GWG | 2019-01-18 | 156 |
| K180372 | Aurora Evacuator | GEI | 2018-04-09 | 56 |
Recalls
openFDA lists no recalls under a recalling firm named Rebound Therapeutics.
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:
- Rebound Therapeutics (6)
- Rebound Therapeutics Corporation (2)
Frequently asked questions
How many FDA 510(k) clearances are listed under Rebound Therapeutics?
FDA lists 8 510(k) clearances under 2 spellings of the applicant name “Rebound Therapeutics” (first 2018, latest 2023), 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 Rebound Therapeutics?
The median time from FDA receipt to decision across 510(k)s cleared under the name Rebound Therapeutics is 92 days. Since 2017: 92 days, versus 113 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Rebound Therapeutics?
The most frequent FDA product codes under this applicant name are GEI (Electrosurgical, Cutting & Coagulation & Accessories, 4); GWG (Endoscope, Neurological, 4).
Next steps
- See all 8 Rebound Therapeutics clearances with predicates and recalls
- Run predicate analysis for product code GEI, Rebound 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 (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.