Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Brainlab AG — Predicate Candidate Screening

135 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

141 daysmedian FDA review time
269 days90th percentile
135clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K252476Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart LBrainlab AG2025-10-16700
K252562Spine & Trauma Navigation InstrumentsBrainlab AG2025-09-12290
K243432Vascular Navigation PAD 2.0; Navigation Software Vascular PABrainlab AG2025-07-222590
K243142Cranial 4Pi ImmobilizationBrainlab AG2025-06-232660
K250440RT Elements (4.5); (Elements) Multiple Brain Mets SRS; (ElemBrainlab AG2025-06-171230
K243633Brainlab Elements (7.0); Brainlab Elements Image Fusion (5.0Brainlab AG2025-06-132000
K242569Mixed Reality Spine NavigationBrainlab AG2025-05-162610
K243698Alignment System Cranial, with Alignment Software Cranial wiBrainlab AG2025-01-28600
K240431ExacTrac Dynamic (2.0); ExacTrac Dynamic SurfaceBrainlab AG2024-07-241610
K240701Drill Guide; Drill Bit; Spine & Trauma NavigationBrainlab AG2024-05-23700
K232759Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart LBrainlab AG2024-05-212561
K234047Automatic RegistrationBrainlab AG2024-03-20900
K223864Alignment System Cranial, Alignment Software Cranial, Cirq ABrainlab AG2023-09-092600
K223553Spine Planning (2.0), Elements Spine Planning, Elements PlanBrainlab AG2023-08-022500
K223288Cranial Navigation, Navigation Software Cranial, Navigation Brainlab AG2023-07-212690
K223106Brainlab Elements Image Fusion, Contouring (4.5);Image FusioBrainlab AG2023-07-142870
K231052ExacTrac Dynamic 1.1.2Brainlab AG2023-05-11280
K223734ENT EMBrainlab AG2023-04-271350
K223552Brainlab Elements – Trajectory Planning (2.6), Elements SterBrainlab AG2023-04-191450
K223279RT Elements (4.0)Brainlab AG2023-03-141410
K222966Cirq Arm System (2.0);Alignment System SpineBrainlab AG2022-10-27301
K213989Cranial EM SystemBrainlab AG2022-09-082620
K221618Spine & Trauma Navigation, Spine Navigation, Navigation SoftBrainlab AG2022-08-30880
K220652Knee 3Brainlab AG2022-06-03880
K220338ExacTrac DynamicBrainlab AG2022-04-29811
K213930Brainlab Elements Guide XT, Guide 3.0Brainlab AG2022-04-191240
K212245Spine and Trauma Navigation System, Spine & Trauma 3D NavigaBrainlab AG2022-04-132680
K212420Brainlab Elements, Brainlab Elements Contouring, Brainlab ElBrainlab AG2021-12-161340
K210989Cirq, Cirq Robotic Alignment System, Cirq Robotic Alignment Brainlab AG2021-11-122240
K211544Trajectory Planning, Elements Trajectory Planning, Elements Brainlab AG2021-11-031680
K211939ExacTrac DynamicBrainlab AG2021-07-22290
K203681RT Elements, Cranial SRS w/ Cones, Multiple Brain Mets SRS, Brainlab AG2021-04-091130
K203679Automatic RegistrationBrainlab AG2021-03-18910
K201752Disposable Pre-calibrated SuctionBrainlab AG2021-01-292170
K202320CIRQ Robotic Alignment Module, Cirq, Cirq Robotic Alignment Brainlab AG2020-12-231280
K203173ExacTrac DynamicBrainlab AG2020-11-12170
K192703Cranial Image Guided Surgery System, Navigation Software CraBrainlab AG2020-10-083770
K202050Cranial 4Pi ImmobilizationBrainlab AG2020-08-19260
K201276ExacTrac DynamicBrainlab AG2020-07-13610
K193307HIP7Brainlab AG2020-06-021860
K191014Elements ViewerBrainlab AG2020-01-232810
K190250Microscope NavigationBrainlab AG2019-09-062110
K183605Spine & Trauma NavigationBrainlab AG2019-08-292460
K191285Spine & Trauma NavigationBrainlab AG2019-06-11290
K190042Brainlab Elements Image Fusion AngioBrainlab AG2019-04-251060
K190664RT Elements, Cranial SRS, Spine SRS, Multiple Brain Mets SRSBrainlab AG2019-04-12280
K172820Microscope Navigation SoftwareBrainlab AG2018-03-011640
K170816Elements Image Fusion, Elements Cranial Distortion CorrectioBrainlab AG2017-09-261900
K170750RT Elements, Cranial SRS, Spine SRS, Multiple Brain Mets SRSBrainlab AG2017-08-241640
K153653DICOM ViewerBrainlab AG2016-04-131140

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