510(k) · Cleared
ClearedENT EM
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Brainlab AG · PGW Ear, Nose, And Throat Stereotaxic Instrument
Cleared on Apr 27, 2023 as substantially equivalent to K200723 (Medtronic Navigation, Inc., 2020) after a 135-day review. Its family tree reaches back 4 generations to 2000.
- Decided
- Apr 27, 2023
- Review
- 135 days
- Class
- Class II
- Product code
- PGW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K001284 (2000). No later device cites it as a predicate yet.
- Root · 4 generations backK001284 Stealthstation System Goldeneye Micro-Magnetic Tracking SystemMedtronic Surgical Navigation Technologies · 2000 · Recalled
- 3 generations backK153247 Fusion Compact Navigation SystemMedtronic Navigation, Inc. · 2016
- 2 generations backK170018 StealthStationTM S8 ENT SoftwareMedtronic Navigation, Inc. · 2017
- 1 generation backK200723 StealthStation FlexENT (9736242), StealthStation S8 ENT Software…Medtronic Navigation, Inc. · 2020
- This deviceK223734 ENT EMBrainlab AG · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K001284 | Stealthstation System Goldeneye Micro-Magnetic Tracking System | Medtronic Surgical Navigation Technologies | 2000 | 28 |
| −3 | K153247 | Fusion Compact Navigation System | Medtronic Navigation, Inc. | 2016 | — |
| −2 | K170018 | StealthStationTM S8 ENT Software | Medtronic Navigation, Inc. | 2017 | — |
| −1 | K200723 | StealthStation FlexENT (9736242), StealthStation S8 ENT Software (9735762) | Medtronic Navigation, Inc. | 2020 | — |
| 0 (this device) | K223734 | ENT EM | Brainlab AG | 2023 | — |
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 PGW? 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 PGW device
- #1 K261540 Cube 4D Navigation System, VirtuEye Proscore 12.9 · 6 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 |
|---|---|---|---|
| * | K200723 | StealthStation FlexENT (9736242), StealthStation S8 ENT Software (9735762)Summary page 4…882.4560 Regulatory Class Class II Panel Neurology - Ear Nose & Throat Predicate Device(s) K200723 StealthStation FlexENT, StealthStation S8 ENT Software 1.3 Reference Device(s) K213989 Cranial EM System… | 2020 |
| † | K213989 | Cranial EM System | 2022 |
What descends from it?
No later submission names this one as a predicate yet.
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 23 years and passes through 3 companies; a new generation was cleared every 3.1 years on median.
- 1 of the 4 ancestors has a recall of any class.
- 1 other device also cites its predicate K200723.
How does its category compare?
All PGW devicesPGW Ear, Nose, And Throat Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · PGW
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PGW
100in 2020
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PGW
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PGW
220in 2025
MAUDE reports naming product code PGW, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 4 | 116 | 0 | 7 |
| 2015 | 1 | — | 0 | 14 |
| 2016 | 9 | 115 | 0 | 33 |
| 2017 | 4 | 125 | 0 | 42 |
| 2018 | 2 | — | 0 | 96 |
| 2019 | 1 | — | 3 | 247 |
| 2020 | 8 | 100 | 0 | 161 |
| 2021 | 1 | — | 1 | 190 |
| 2022 | 2 | — | 0 | 166 |
| 2023 | 2 | — | 1 | 200 |
| 2024 | 0 | — | 0 | 274 |
| 2025 | 1 | — | 1 | 220 |
| 2026 | 3 | 65 | 0 | — |
What is it indicated for?
ENT EM is intended as an image-guided planning and navigation system to enable ENT procedures.
The device is indicated for any medical condition in which a reference to a rigid anatomical structure
can be identified relative to images (CT, CTA, X-Ray, MR, MRA and ultrasound) of the anatomy,
such as:
* Intranasal structures and Paranasal Sinus Surgery
o Functional endoscopic sinus surgery (FESS)
o Intranasal structures and paranasal sinus surgery, including revision and distorted anatomy
* Anterior skull base procedures
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223734 · printed Nov 5, 2026
Cite this page
510(k) Report. “K223734: ENT EM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K223734
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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