Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Point Robotics MedTech, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
155 daysmedian FDA review time
193 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252989 | “POINT” Kinguide Agile Hybrid Navigation System; DRF Accesso | Point Robotics MedTech, Inc. | 2026-02-20 | 155 | 0 |
| K252755 | POINT Kinguide Agile Robotic Arm Surgical Stereotactic Syste | Point Robotics MedTech, Inc. | 2026-01-23 | 147 | 0 |
| K241130 | “POINT” Kinguide Agile Hybrid Navigation System (PSHF01-000) | Point Robotics MedTech, Inc. | 2024-07-24 | 91 | 0 |
| K230087 | “POINT” Kinguide Agile Hybrid Navigation System | Point Robotics MedTech, Inc. | 2023-07-17 | 186 | 0 |
| K220241 | “POINT” Kinguide Robotic-Assisted Surgical System | Point Robotics MedTech, Inc. | 2022-08-09 | 193 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda