Responsive Arthroscopy, Inc.: FDA filings under this applicant name
FDA lists 2 510(k) clearances under the applicant name “Responsive Arthroscopy, Inc.” (first 2025, latest 2026), across 1 product code in 1 review panel. Median 510(k) review time under this name: 60 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 |
|---|---|---|
| 2025 | 1 | 58 |
| 2026 | 1 | 63 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Responsive Arthroscopy, Inc. took a median 60 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 74 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | 2 | 2 |
Review panels
- Orthopedic (2)
Most recent Responsive Arthroscopy, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K261632 | Thunderbolt System | MBI | 2026-07-20 | 63 |
| K243726 | Osprey Suture Anchor | MBI | 2025-01-30 | 58 |
Recalls
openFDA lists no recalls under a recalling firm named Responsive Arthroscopy, Inc..
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Responsive Arthroscopy, LLC (11 510(k)s)
- Responsive Orthopedics, LLC (2 510(k)s)
- Responsive Respiratory (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Responsive Arthroscopy, Inc.?
FDA lists 2 510(k) clearances under the applicant name “Responsive Arthroscopy, Inc.” (first 2025, latest 2026), 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 Responsive Arthroscopy, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Responsive Arthroscopy, Inc. is 60 days.
Which FDA product codes appear under Responsive Arthroscopy, Inc.?
The most frequent FDA product codes under this applicant name are MBI (Fastener, Fixation, Nondegradable, Soft Tissue, 2).
Next steps
- See all 2 Responsive Arthroscopy, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MBI, Responsive Arthroscopy, Inc.'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.