510(k) · Cleared
ClearedKarl Storz Navigationpanel Unit (Npu) System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
KARL STORZ Endoscopy-America, Inc. · HAW Neurological Stereotaxic Instrument
Cleared on Sep 27, 2012 as substantially equivalent to K014256 (Brainlab AG, 2002) after a 73-day review. Its family tree reaches back 2 generations to 1999. 5 later devices descend from it.
- Decided
- Sep 27, 2012
- Review
- 73 days
- Class
- Class II
- Product code
- HAW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K983831 (1999). 4 ancestors in all. 5 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK983831 VECTORVISION2Brainlab AG · 1999
- 1 generation backK014256 Kolibri Igs SystemsBrainlab AG · 2002
- This deviceK122096 Karl Storz Navigationpanel Unit (Npu) SystemKARL STORZ Endoscopy-America, Inc. · 2012
- Descendant · cites it directly · 2 of its ownK161555 KARL STORZ NAV1 Electromagnetic Navigation SystemKarl Storz Endoscopy America, Inc. · 2016
- Descendant · cites it directly · 1 of its ownK163439 NaviENTClaronav, Inc. · 2017
- Descendant · 2 generations on · 0 of its ownK243053 Navient Image Guided Navigation System (ENT) (955-NC-NC)Claronav · 2025
- Descendant · 2 generations on · 0 of its ownK201174 TruDi CuretteAcclarent, Inc. · 2020
- Descendant · 2 generations on · 0 of its ownK180948 TruDi NAV Suction InstrumentsAcclarent, Inc. · 2018 · Recalled
Most influential descendants
Showing 5 of 5 · See all- K161555KARL STORZ NAV1 Electromagnetic Navigation SystemKarl Storz Endoscopy America, Inc. · 2016 · cites it directly2descendants
- K163439NaviENTClaronav, Inc. · 2017 · cites it directly1descendant
- K243053Navient Image Guided Navigation System (ENT) (955-NC-NC)Claronav · 2025 · 2 generations on0descendants
- K201174TruDi CuretteAcclarent, Inc. · 2020 · 2 generations on0descendants
- K180948TruDi NAV Suction InstrumentsAcclarent, Inc. · 2018 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K983831 | VECTORVISION2 | Brainlab AG | 1999 | — |
| −1 | K014256 | Kolibri Igs Systems | Brainlab AG | 2002 | — |
| 0 (this device) | K122096 | Karl Storz Navigationpanel Unit (Npu) System | KARL STORZ Endoscopy-America, Inc. | 2012 | — |
| +1 | K161555 | KARL STORZ NAV1 Electromagnetic Navigation System | Karl Storz Endoscopy America, Inc. | 2016 | — |
| +1 | K163439 | NaviENT | Claronav, Inc. | 2017 | — |
| +2 | K243053 | Navient Image Guided Navigation System (ENT) (955-NC-NC) | Claronav | 2025 | — |
| +2 | K201174 | TruDi Curette | Acclarent, Inc. | 2020 | — |
| +2 | K180948 | TruDi NAV Suction Instruments | Acclarent, Inc. | 2018 | 5 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K014256 | Kolibri Igs SystemsSummary page 1…ic stereotaxic instrument Regulation Number: 21 CFR 882.4560 Product Code: HAW Predicate Device(s): BrainLAB AG: Kolibri Image Guided Surgery System (K014256) Device Description: The Karl Storz Navigation Panel Unit (NPU) System is a multi-component system to be used as a positioning ai… | 2002 |
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 13 years and passes through 2 companies; a new generation was cleared every 10.2 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K161555 (Karl Storz Endoscopy America, Inc., 2016) has gone furthest, with 2 descendants of its own.
- 6 other devices also cite its predicate K014256.
How does its category compare?
All HAW devicesHAW Neurological Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
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?
The Navigation Panel Unit System (NPU) is an intraoperative image guided localization system that links a freehand probe tracked by a passive marker sensor system to a virtual computer image space on a patient's preoperative diagnostic image data set. The system is intended to be used as a positioning aid for navigation in ENT surgery, including but not limited to endoscopic surgery. The NPU is indicated for any medical condition in which the use of…
Read the full statement (135 words)
The Navigation Panel Unit System (NPU) is an intraoperative image guided localization system that links a freehand probe tracked by a passive marker sensor system to a virtual computer image space on a patient's preoperative diagnostic image data set. The system is intended to be used as a positioning aid for navigation in ENT surgery, including but not limited to endoscopic surgery. The NPU is indicated for any medical condition in which the use of stereotacti& surgery may be appropriate and where a reference to a rigid anatomical structure can be identified relative to the radiological imaging-based model of the anatomy. Surgery procedures include but are not limited to the following: transphenoidal procedures, maxillary antrostomnies, ethmoidectomies, sphenoidectomies, sphenoid explorations, turbinate resections, frontal sinusotomnies, intranasal procedures, intranasal tumor resections, otologic surgery, and ENT skull base surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122096 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122096: Karl Storz Navigationpanel Unit (Npu) System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122096
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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