# Brainlab AG

- Location (FDA's records): Munich, DE
- FDA decisions: 145 (1992–2026): 145 510(k) clearances
- Names in FDA's records: Brainlab AG (135); Brainlab (3); Brainlab SE (3); Brainlab, Inc. (2); Brainlab , Ltd. (2)
- Product codes: HAW (59), IYE (23), OLO (22), LLZ (14), MUJ (12), QIH (3), LHN (3), JAI (2), PGW (1), HBL (1), SBF (1), JAK (1)
- 510(k) review time since 2016: median 141 days, against 115 for FDA's reviews in the same codes and years (21 of 53 faster)
- Predicates its devices cite: 210 (178 its own); citations of its devices by later devices: 302 (178 its own)
- Recalls linked to its devices: 46 (2 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Medtronic Navigation, Inc.: 6 (https://510kreport.com/company/medtronic-navigation)
- Brainlab Med. Computersysteme GmbH: 3 (https://510kreport.com/company/brainlab-med-computersysteme)
- Medtronic Surgical Navigation Technologies: 3 (https://510kreport.com/company/medtronic-surgical-navigation-technologies)
- Globalmed: 2 (https://510kreport.com/company/globalmed)
- Varian Medical Systems, Inc.: 2 (https://510kreport.com/company/varian-medical-systems)
- Voyant Health, Ltd.: 1 (https://510kreport.com/company/voyant-health)
- FHC, Inc.: 1 (https://510kreport.com/company/fhc)
- Stryker Corp.: 1 (https://510kreport.com/company/stryker)

## Firms that cite its devices most
- Mako Surgical Corp.: 13 (https://510kreport.com/company/mako-surgical)
- Aesculap Implant System, Inc.: 6 (https://510kreport.com/company/aesculap-implant-system)
- Medos International SARL: 5 (https://510kreport.com/company/medos-international)
- Esaote, S.p.A.: 5 (https://510kreport.com/company/esaote)
- Orthalign, Inc.: 4 (https://510kreport.com/company/orthalign)
- Medcom GmbH: 3 (https://510kreport.com/company/medcom)
- Computerized Medical Systems, Inc.: 3 (https://510kreport.com/company/computerized-medical-systems)
- Calypso Medical Technologies, Inc.: 3 (https://510kreport.com/company/calypso-medical-technologies)

## Its most-cited devices
- K040368: Vectorvision Hip 3.0 (2004), cited by 12
- K983831: VECTORVISION2 (1999), cited by 12
- K021306: Vectorvision CT-Free Knee (2002), cited by 10
- K070106: VV Fluoro 3D (2007), cited by 10
- K010602: Vectorvision Hip (2001), cited by 9
- K052213: Navigation SW Hip 3.1 on CI (2005), cited by 7

## Recent decisions
- K261655: RT Elements (4.6) (Oct 5, 2026)
- K262257: Spine Planning (3.0); Spine & Trauma Navigation; Alignment System Spine (Sep 30, 2026)
- K254010: ExacTrac Dynamic (2.0.2); ExacTrac Dynamic Surface (Jan 14, 2026)
- K252476: Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart Layout (Oct 16, 2025)
- K252562: Spine & Trauma Navigation Instruments (Sep 12, 2025)
- K243432: Vascular Navigation PAD 2.0; Navigation Software Vascular PAD (Jul 22, 2025)
- K243142: Cranial 4Pi Immobilization (Jun 23, 2025)
- 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 (Jun 17, 2025)

Source page: https://510kreport.com/company/brainlab