510(k) · Cleared
ClearedCatheter Introducer for the Stealthstation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Surgical Navigation Technologies · HAW Neurological Stereotaxic Instrument
Cleared on Jan 3, 2003 after a 186-day review. The FDA summary names its predicate without a number. 8 of the 464 devices in its family, counting itself, have a Class I recall. 463 later devices descend from it.
- Decided
- Jan 3, 2003
- Review
- 186 days
- Class
- Class II
- Product code
- HAW
- Recalls
- None
- Predicates
- 0
463 later devices descend from it, 5 citing it directly. 8 of the 464 devices in this family, counting this one, have a Class I recall.
- This deviceK022126 Catheter Introducer for the Stealthstation SystemMedtronic Surgical Navigation Technologies · 2003
- Descendant · cites it directly · 278 of its ownK053610 AbarisTraxtal Technologies, Inc. · 2006 · Recalled
- Descendant · 2 generations on · 222 of its ownK121498 PercunavPhilips Health Care · 2012
- Descendant · 3 generations on · 211 of its ownK132304 Epiq Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2013 · Recalled
- Descendant · cites it directly · 133 of its ownK033223 Zimmer Ortho Guidance Systems- Hip InstrumentsZimmer, Inc. · 2004
- Descendant · cites it directly · 133 of its ownK033011 Zimmer Ortho Guidance Systems- Knee InstrumentsZimmer, Inc. · 2004
Showing 5 of 463 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 463 · See all- K053610AbarisTraxtal Technologies, Inc. · 2006 · cites it directly278descendants
- K121498PercunavPhilips Health Care · 2012 · 2 generations on222descendants
- K132304Epiq Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2013 · 3 generations on211descendants
- K033223Zimmer Ortho Guidance Systems- Hip InstrumentsZimmer, Inc. · 2004 · cites it directly133descendants
- K033011Zimmer Ortho Guidance Systems- Knee InstrumentsZimmer, Inc. · 2004 · cites it directly133descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K022126 | Catheter Introducer for the Stealthstation System | Medtronic Surgical Navigation Technologies | 2003 | — |
| +1 | K053610 | Abaris | Traxtal Technologies, Inc. | 2006 | 3 |
| +2 | K121498 | Percunav | Philips Health Care | 2012 | — |
| +3 | K132304 | Epiq Diagnostic Ultrasound System | Philips Ultrasound, Inc. | 2013 | 36 |
| +1 | K033223 | Zimmer Ortho Guidance Systems- Hip Instruments | Zimmer, Inc. | 2004 | — |
| +1 | K033011 | Zimmer Ortho Guidance Systems- Knee Instruments | Zimmer, Inc. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 3 | 0 |
| 2005 | 3 | 0 |
| 2006 | 5 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 5 | 0 |
| 2010 | 5 | 1 |
| 2011 | 6 | 0 |
| 2012 | 4 | 0 |
| 2013 | 6 | 0 |
| 2014 | 14 | 0 |
| 2015 | 19 | 1 |
| 2016 | 22 | 0 |
| 2017 | 36 | 0 |
| 2018 | 21 | 1 |
| 2019 | 29 | 1 |
| 2020 | 32 | 1 |
| 2021 | 33 | 1 |
| 2022 | 36 | 0 |
| 2023 | 39 | 0 |
| 2024 | 40 | 0 |
| 2025 | 56 | 2 |
| 2026 | 46 | 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.
8 devices in this family have a Class I recall. 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? (2)
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 |
|---|---|---|---|
| * | — | StealthStation System Named without a submission number | |
| * | — | Radionics Optical Tracking System Named without a submission number |
What descends from it? (463)
See all 4635 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K053610 | Abaris | 2006 | 278 |
| K033223 | Zimmer Ortho Guidance Systems- Hip Instruments | 2004 | 133 |
| K033011 | Zimmer Ortho Guidance Systems- Knee Instruments | 2004 | 133 |
| K042391 | Kolibri Image Guided Surgery System | 2004 | 72 |
| K141833 | Stylet, 23CM, Skull-Mount Patient Tracker, Non-Invasive Patient Tracker, Tracer Pointer… | 2015 | 3 |
Has anything in its family been recalled? (8 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K092467Vectorvision Cranial, Vectorvision Ent, Kolibri Cranial, Kolibri Ent, Cranial Essential, Cranial UnlimitedBrainlab AG · 2010 · 3 generations on · ◆ in the 2010 descendants bar of FIG. 11 Class I recall
- K151359ROSA BrainMedtech S.A · 2015 · 5 generations on · ◆ in the 2015 descendants bar of FIG. 11 Class I recall
- K172444ROSA BRAIN (v3.0.0.5)Medtech S.A · 2018 · 6 generations on · ◆ in the 2018 descendants bar of FIG. 11 Class I recall
- K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 7 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
- K182417ROSA ONE Brain ApplicationMedtech S.A · 2019 · 7 generations on · ◆ in the 2019 descendants bar of FIG. 11 Class I recall
- K200511ROSA ONE Brain applicationMedtech S.A · 2020 · 8 generations on · ◆ in the 2020 descendants bar of FIG. 11 Class I recall
- K242670Lumify Diagnostic Ultrasound SystemPhilips Ultrasound · 2025 · 8 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall
- K242519Lumify Diagnostic Ultrasound SystemPhilips Ultrasound · 2025 · 8 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall
Nearest 5 of 8; all are on the web page.
What does this lineage say?
- Of its descendants, K053610 (Traxtal Technologies, Inc., 2006) has gone furthest, with 278 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?
The StealthStationB System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The StealthStationB System 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, a long bone, or vertebra, can be identified relative to a CT or MR based model or fluoroscopy images of the anatomy.…
Read the full statement (194 words)
The StealthStationB System is intended as an aid for precisely locating anatomical structures in either
open or percutaneous procedures. The StealthStationB System 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, a long bone, or vertebra, can be identified relative to a CT or MR based model
or fluoroscopy images of the anatomy.
Example procedures include, but are not limited to:
Cranial Procedures: Spinal Procedures:
Cranial Biopsies Spinal Implant Procedures, such as Pedicle Screw
Placement
Tumor Resections
Craniotomies/ Craniectomies ENT Procedures:
Skull Base procedures Transphenoidal Procedures
Thalamotomies/Pallidotomies Intranasal Procedures
Pituitary Tumor Removal Orbital Nerve Decompression Procedures
CSF Leak Repair Optic Nerve Decompression Procedures
Pediatric Catheter Shunt Placement Polyposis Procedures
General Catheter Shunt Placement Endoscopic Dacryocystorhinostomy
Encephalocele Procedures
Orthopedic Procedures: Sinus procedures, such as Maxillary Antrostomies,
Total Knee Arthroplasty (Primary and Revision) Ethmoidectomies, Sphenoidotomies/Sphenoid
Unicompartmental Knee Arthroplasty Explorations, Turbinate Resections,and Frontal
Minimally Invasive Orthopedic Procedures Sinusotomies
Pediatric Orthopedics
Total Hip Replacement (Primaiy and Revision)
Periacetabular Osteotomies
Tumor Resection and Bone/Joint Reconstruction
Femoral Revision
Stabilization and Repair of Pelvic Fractures
(Including but not Limited to Acetabular Fractures)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022126 · printed Nov 4, 2026
Cite this page
510(k) Report. “K022126: Catheter Introducer for the Stealthstation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K022126
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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