Point Robotics MedTech, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Point Robotics MedTech, Inc.” (first 2022, latest 2026), across 1 product code in 1 review panel. Median 510(k) review time under this name: 155 days. Since 2017 the median was 155 days, against 91 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 |
|---|---|---|
| 2022 | 1 | 193 |
| 2023 | 1 | 186 |
| 2024 | 1 | 91 |
| 2025 | 0 | — |
| 2026 | 2 | 151 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Point Robotics MedTech, Inc. took a median 155 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 91 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| OLO | Orthopedic Stereotaxic Instrument | 5 | 5 |
Review panels
- Orthopedic (5)
Most recent Point Robotics MedTech, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K252989 | POINT Kinguide Agile Hybrid Navigation System; DRF Accessories Set | OLO | 2026-02-20 | 155 |
| K252755 | POINT Kinguide Agile Robotic Arm Surgical Stereotactic System | OLO | 2026-01-23 | 147 |
| K241130 | POINT Kinguide Agile Hybrid Navigation System (PSHF01-000) | OLO | 2024-07-24 | 91 |
| K230087 | POINT Kinguide Agile Hybrid Navigation System | OLO | 2023-07-17 | 186 |
| K220241 | POINT Kinguide Robotic-Assisted Surgical System | OLO | 2022-08-09 | 193 |
Recalls
openFDA lists no recalls under a recalling firm named Point Robotics MedTech, 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.
- Point of View Optical Outlet, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Point Robotics MedTech, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Point Robotics MedTech, Inc.” (first 2022, 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 Point Robotics MedTech, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Point Robotics MedTech, Inc. is 155 days. Since 2017: 155 days, versus 91 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Point Robotics MedTech, Inc.?
The most frequent FDA product codes under this applicant name are OLO (Orthopedic Stereotaxic Instrument, 5).
Next steps
- See all 5 Point Robotics MedTech, Inc. clearances with predicates and recalls
- Run predicate analysis for product code OLO, Point Robotics MedTech, 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, 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.