Brainlab AG: FDA clearances and approvals
Brainlab AG has 135 FDA 510(k) clearances (first 1996, latest 2025), across 14 product codes in 4 review panels. Median 510(k) review time: 141 days. Since 2017 its median was 141 days, against 120 days for all cleared 510(k)s in the same product codes. openFDA lists 47 product recalls by a recalling firm named Brainlab AG. It is the industry lead sponsor of 1 device clinical trial on ClinicalTrials.gov.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 5 | 129 |
| 2013 | 1 | 275 |
| 2014 | 3 | 134 |
| 2015 | 0 | — |
| 2016 | 1 | 114 |
| 2017 | 2 | 177 |
| 2018 | 1 | 164 |
| 2019 | 5 | 106 |
| 2020 | 7 | 128 |
| 2021 | 7 | 134 |
| 2022 | 7 | 88 |
| 2023 | 8 | 198 |
| 2024 | 4 | 126 |
| 2025 | 8 | 162 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Brainlab AG's cleared 510(k)s took a median 141 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 120 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HAW | Neurological Stereotaxic Instrument | 57 | 57 |
| IYE | Accelerator, Linear, Medical | 21 | 21 |
| OLO | Orthopedic Stereotaxic Instrument | 21 | 21 |
| LLZ | System, Image Processing, Radiological | 13 | 13 |
| MUJ | System, Planning, Radiation Therapy Treatment | 11 | 11 |
| JAI | Couch, Radiation Therapy, Powered | 2 | 2 |
| LHN | System, Radiation Therapy, Charged-Particle, Medical | 2 | 2 |
| QIH | Automated Radiological Image Processing Software | 2 | 2 |
| HBL | Holder, Head, Neurosurgical (Skull Clamp) | 1 | 1 |
| JAK | System, X-Ray, Tomography, Computed | 1 | 1 |
Plus 4 more product codes.
Review panels
- Neurology (59)
- Radiology (53)
- Orthopedic (22)
- Ear, Nose and Throat (1)
Most recent Brainlab AG 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K252476 | Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart Layout | LLZ | 2025-10-16 | 70 |
| K252562 | Spine & Trauma Navigation Instruments | OLO | 2025-09-12 | 29 |
| K243432 | Vascular Navigation PAD 2.0; Navigation Software Vascular PAD | OWB | 2025-07-22 | 259 |
| K243142 | Cranial 4Pi Immobilization | IYE | 2025-06-23 | 266 |
| K250440 | RT Elements (4.5); (Elements) Multiple Brain Mets SRS; (Elements) Cranial SRS; (Elements) Spine SRS; (Elements) Cranial SRS w/ Cones; (Elements) RT Planning Platform; (Elements) Dose Review; (Elements) Retreatment Review; Elements Segmentation [Cranial , Basal Ganglia, Head & Neck, Pelvic, Spine, Thoracic & Spine, Extracranial] RT; Elements AI Tumor Segmentation RT; Elements SmartBrush [Angio, Spine] RT; Elements Object Management RT | MUJ | 2025-06-17 | 123 |
| K243633 | Brainlab Elements (7.0); Brainlab Elements Image Fusion (5.0); Brainlab Elements Image Fusion Angio (1.0); Brainlab Elements Contouring (5.0); Brainlab Elements Fibertracking (3.0); Brainlab Elements BOLD MRI Mapping (1.0) | QIH | 2025-06-13 | 200 |
| K242569 | Mixed Reality Spine Navigation | SBF | 2025-05-16 | 261 |
| K243698 | Alignment System Cranial, with Alignment Software Cranial with LITT; Cirq Alignment Software Cranial Biopsy; Cirq Alignment Software Cranial sEEG; VarioGuide Alignment Software Cranial; Cirq Alignment Software Cranial LITT | HAW | 2025-01-28 | 60 |
| K240431 | ExacTrac Dynamic (2.0); ExacTrac Dynamic Surface | IYE | 2024-07-24 | 161 |
| K240701 | Drill Guide; Drill Bit; Spine & Trauma Navigation | OLO | 2024-05-23 | 70 |
125 earlier clearances. See the full list in Caduvo.
Recalls
47 product recalls in 41 recall events; 4 initiated in the last five years. Most recent: 2025-02-10.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Device clinical trials
Brainlab AG is the industry lead sponsor of 1 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:
- NCT05891002: Accuracy of Robotically Assisted Cranial Biopsies (Recruiting, started 2023-11-01)
Frequently asked questions
How many FDA 510(k) clearances does Brainlab AG have?
Brainlab AG has 135 FDA 510(k) clearances (first 1996, latest 2025), across 14 product codes in 4 review panels.
How long does FDA take to clear Brainlab AG's 510(k)s?
The median time from FDA receipt to decision across Brainlab AG's cleared 510(k)s is 141 days. Since 2017: 141 days, versus 120 days for all cleared 510(k)s in the same product codes.
What devices does Brainlab AG make?
Its most frequent FDA product codes are HAW (Neurological Stereotaxic Instrument, 57); IYE (Accelerator, Linear, Medical, 21); OLO (Orthopedic Stereotaxic Instrument, 21).
Has Brainlab AG had device recalls?
openFDA lists 47 product recalls in 41 recall events by a recalling firm whose name matches Brainlab AG; the most recent began 2025-02-10. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 135 Brainlab AG clearances with predicates and recalls
- Run predicate analysis for product code HAW, Brainlab AG's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.