510(k) · Cleared
ClearedNaviENT
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Claronav, Inc. · HAW Neurological Stereotaxic Instrument
Cleared on Sep 1, 2017 as substantially equivalent to K122096 (KARL STORZ Endoscopy-America, Inc., 2012) after a 267-day review. Its family tree reaches back 3 generations to 1999. 1 later device descends from it.
- Decided
- Sep 1, 2017
- Review
- 267 days
- Class
- Class II
- Product code
- HAW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K983831 (1999). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK983831 VECTORVISION2Brainlab AG · 1999
- 2 generations backK014256 Kolibri Igs SystemsBrainlab AG · 2002
- 1 generation backK122096 Karl Storz Navigationpanel Unit (Npu) SystemKARL STORZ Endoscopy-America, Inc. · 2012
- This deviceK163439 NaviENTClaronav, Inc. · 2017
- Descendant · cites it directly · 0 of its ownK243053 Navient Image Guided Navigation System (ENT) (955-NC-NC)Claronav · 2025
Most influential descendants
Showing 1 of 1 · See all- K243053Navient Image Guided Navigation System (ENT) (955-NC-NC)Claronav · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K983831 | VECTORVISION2 | Brainlab AG | 1999 | — |
| −2 | K014256 | Kolibri Igs Systems | Brainlab AG | 2002 | — |
| −1 | K122096 | Karl Storz Navigationpanel Unit (Npu) System | KARL STORZ Endoscopy-America, Inc. | 2012 | — |
| 0 (this device) | K163439 | NaviENT | Claronav, Inc. | 2017 | — |
| +1 | K243053 | Navient Image Guided Navigation System (ENT) (955-NC-NC) | Claronav | 2025 | — |
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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K122096 | Karl Storz Navigationpanel Unit (Npu) SystemSummary page 4…ent Classification Regulation #: 21 CFR 882.4560 Classification Panel: ENT Predicate Device: Karl Storz Navigation Panel Unit (NPU) System (K122096) DEVICE DESCRIPTION NaviENT is a cart-based, computerized, image-guided navigational system, operating as a combined package fo… | 2012 |
| † | K964229 | Regulus Navigator | 1997 |
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 |
|---|---|---|---|
| K243053 | Navient Image Guided Navigation System (ENT) (955-NC-NC) | 2025 | 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 18 years and passes through 3 companies; a new generation was cleared every 4.9 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K243053 (Claronav, 2025) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K122096.
How does its category compare?
All HAW devicesHAW Neurological Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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?
NaviENT is a computerized surgical navigation system intended to guide sinus and trans-nasal skull base endoscopic surgery by dynamically presenting the location of the tip of a surgical instrument mapped to a corresponding location in a pre-acquired CT scan of the patient’s head. The device is intended for use by a qualified ENT surgeon (otolaryngologist). NaviENT is indicated for any medical condition in which the use of stereotactic surgery may be…
Read the full statement (126 words)
NaviENT is a computerized surgical navigation system intended to guide sinus and trans-nasal skull base endoscopic surgery by dynamically presenting the location of the tip of a surgical instrument mapped to a corresponding location in a pre-acquired CT scan of the patient’s head. The device is intended for use by a qualified ENT surgeon (otolaryngologist).
NaviENT is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, can be identified relative to images 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, and ENT related skull base surgery.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K163439 · printed Nov 6, 2026
Cite this page
510(k) Report. “K163439: NaviENT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K163439
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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