510(k) · Cleared
ClearedIplan Flow
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Brainlab AG · HAW Neurological Stereotaxic Instrument
Cleared on Mar 23, 2006 as substantially equivalent to K041330 (Brainlab AG, 2004) after a 129-day review. Its family tree reaches back 3 generations to 1999. 1 later device descends from it.
- Decided
- Mar 23, 2006
- Review
- 129 days
- Class
- Class II
- Product code
- HAW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K983410 (1999). 6 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK983410 @ TargetBrainlab AG · 1999
- 2 generations backK020631 IPLANBrainlab AG · 2002
- 1 generation backK041330 Iplan! FlowBrainlab AG · 2004
- This deviceK053164 Iplan FlowBrainlab AG · 2006
- Descendant · cites it directly · 0 of its ownK201435 Molecular Flow SimulationsTherataxis, LLC · 2021
Most influential descendants
Showing 1 of 1 · See all- K201435Molecular Flow SimulationsTherataxis, LLC · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K983410 | @ Target | Brainlab AG | 1999 | — |
| −2 | K020631 | IPLAN | Brainlab AG | 2002 | — |
| −1 | K041330 | Iplan! Flow | Brainlab AG | 2004 | — |
| 0 (this device) | K053164 | Iplan Flow | Brainlab AG | 2006 | — |
| +1 | K201435 | Molecular Flow Simulations | Therataxis, LLC | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HAW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new HAW device
- #1 K253856 Geniant Cranial (Navigated Neurosurgical…score 15.0 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K041330 | Iplan! FlowSummary page 1…ice Name: Trade name: iPlan Flow Common/Classification Name: Planning System/Stereotactic Instrument Predicate Device: iP~anIFLOW (K 041330) Device Classification Name: Instrument, Stereotactic Regulatory Class: Class 11 Intended Use: iPlan Flow is designed as a pla… | 2004 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K201435 | Molecular Flow Simulations | 2021 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 7 years and passes through 1 company; a new generation was cleared every 2.0 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K201435 (Therataxis, LLC, 2021) has gone furthest, with 0 descendants of its own.
How does its category compare?
All HAW devicesHAW Neurological Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HAW
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HAW
163in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HAW
2in 2025
Class I (9 since 2007) Class II/III not classified
Adverse event reports per year · HAW
3,425in 2025
MAUDE reports naming product code HAW, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 15 | 107 | 2 | 49 |
| 2008 | 12 | 112 | 10 | 53 |
| 2009 | 8 | 221 | 6 | 96 |
| 2010 | 6 | 138 | 28 | 299 |
| 2011 | 4 | 66 | 5 | 1,725 |
| 2012 | 8 | 178 | 4 | 986 |
| 2013 | 3 | 172 | 6 (1) | 1,290 |
| 2014 | 5 | 238 | 5 | 1,606 |
| 2015 | 10 | 232 | 3 | 1,767 |
| 2016 | 9 | 175 | 5 | 1,828 |
| 2017 | 7 | 226 | 2 | 3,505 |
| 2018 | 6 | 112 | 2 (2) | 4,439 |
| 2019 | 10 | 147 | 4 (1) | 6,062 |
| 2020 | 5 | 88 | 1 | 3,480 |
| 2021 | 9 | 168 | 4 (2) | 2,827 |
| 2022 | 7 | 128 | 1 | 1,929 |
| 2023 | 14 | 142 | 4 (1) | 2,510 |
| 2024 | 7 | 107 | 2 (2) | 3,755 |
| 2025 | 9 | 163 | 2 | 3,425 |
| 2026 | 5 | 162 | 6 | — |
What is it indicated for?
iPlan Flow is designed as a planning system for pre- and intraoperative planning of stereotactic or image guided surgery treatments. It is specially designed to display anatomical images of a patient acquired with MR and/or CT as well as images derived from DTI-data acquired with Magnetic Resonance Imaging (MRI). iPlan Flow is a dedicated tool for planning trajectories of intra-cranial catheters. Guidelines for the catheter placement e.g. from catheter…
Read the full statement (190 words)
iPlan Flow is designed as a planning system for pre- and intraoperative planning of stereotactic or image guided surgery treatments. It is specially designed to display anatomical images of a patient acquired with MR and/or CT as well as images derived from DTI-data acquired with Magnetic Resonance Imaging (MRI).
iPlan Flow is a dedicated tool for planning trajectories of intra-cranial catheters. Guidelines for the catheter placement e.g. from catheter suppliers can be visualized and displayed to support the surgeon in improving catheter placement planning. The guidelines, in combination with anatomical information, can be used to suggest areas that are compliant with the guidelines. iPlan Flow does not generate or create rules for the placement of intracranial catheters by any means. iPlan Flow uses MR-DTI and T2-weighted MR images to suggest likely volumes of fluid distribution.
The Primary mode of action for iPlan Flow is a device for creating treatment plans for stereotactic or image guided surgical treatment, especially for the creation of plans for the placement of intra-cranial catheters.
The treatment plans can be used in conjunction with other BrainLAB medical devices such as VectorVision for image guided surgical treatment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053164 · printed Nov 6, 2026
Cite this page
510(k) Report. “K053164: Iplan Flow.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053164
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026