FDA product code · Neurology
HAWNeurological Stereotaxic Instrument
Product code HAW covers Neurological Stereotaxic Instrument, a Class II device regulated under 21 CFR 882.4560. FDA has cleared 423 devices in this code, 5 of them in the last 12 months. Median review time across the 423 most recent decisions is 115 days. openFDA lists 197 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 882.4560
- Review panel
- Neurology
- Clearances
- 423
What is happening in HAW right now?
HAW (Neurological Stereotaxic Instrument) has three findings, most consequential first. 3 recalls opened in the last 12 months and not yet terminated (Class II) (Z-2006-2026, Z-0963-2026, Z-0433-2026). 2 first-time filers in the last 12 months, Medivis, Inc. and Bayer Medical Care, Inc (K231897, K250893). The code is crowded, scoring 80 of 100 — 140 companies hold a clearance here and 5 arrived in the last 12 months (HAW:crowding).
| Finding | How much it matters | FDA records |
|---|---|---|
| Recall | Class II recall | Z-2006-2026, Z-0963-2026, Z-0433-2026 |
| New entrant | Worth knowing | K231897, K250893 |
| Crowding | Context | HAW:crowding |
Sources checked: predicate ancestry, recalls, adverse events, new entrants, review time, crowding. Composed . Every finding carries the record ids it was derived from; nothing here is an estimate.
How many devices has FDA cleared in HAW?
FDA has cleared 423 devices under product code HAW since the 510(k) programme began in 1976, 5 of them in the last 12 months.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253663 | Zeta Navigation System | Zeta Surgical, Inc. | |
| K253379 | Stealth AXiS Cranial clinical application | Medtronic Navigation, Inc. | |
| K231897 | NeuroAlign software | Medivis, Inc. | |
| K251317 | SOLOPASS 2.0 System | Intravent Medical Partners | |
| K250893 | Ball Joint Guide Array (66295) | Bayer Medical Care, Inc. | |
| K250505 | EZ-FIDUCIALS | Phasor Health, LLC | |
| K242575 | Stereotaxic Guiding Surgical Devices, NaoTrac S | Brain Navi Biotechnology Co., Ltd. | |
| K241327 | Navient Image Guide Navigation System (955-NC-NC), Cranial | Claronav | |
| K243698 | Alignment System Cranial, with Alignment Software Cranial with LITT; Cirq Alignment Software Cranial Biopsy; Cirq Alignment Software Cranial sEEG; VarioGuide Alignment Software Cranial; Cirq Alignment Software Cranial LITT | Brainlab AG | |
| K243657 | ClearPoint System (Software Version 3.0) | ClearPoint Neuro, Inc. |
How long does FDA review take for HAW?
The median FDA review time for HAW is 115 days, measured across the 423 most recent decisions with both a received date and a decision date.
Review time here is decision date minus date received, as published by FDA. It is elapsed calendar time, not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Are there recalls in HAW?
openFDA lists 197 recall records against product code HAW. A recall record covers one firm's corrective action and may span many device lots.
Z-2006-2026Open, ClassifiedElekta Limited
Locking mechanisms may not properly secure to the Arc system, resulting in shifting of coordinates during procedures.
Z-0963-2026Open, ClassifiedHowmedica Osteonics Corp.
When the device is activated during surgery, the device software issues an error message "Instrument Face Mask (6001385000000) is not valid for this application" resulting in an inability to use the device.
Z-0433-2026Open, ClassifiedElekta Limited
Due to increased risk that paint flakes from the engravings may separate from the device and there is the possibility that the flake may inadvertently enter the wound
Z-0312-2025Open, ClassifiedFHC, Inc.
A complaint was received (MDR 3002250546-2024-00003) prompting an investigation. The investigation revealed a schematic for a spacer tube which is too long relative to the size of other components was included in the build order for Lot 244517 of P/N 66-IT-06P. Use of the product with a spacer tube which is too long could result in intercranial hemorrhaging and brain damage.
Z-0227-2025Open, ClassifiedElekta Instrument AB
Elekta has become aware that Disposable Biopsy Needles can contain some microscopic debris on the inside of the biopsy needle. The material in the debris is stainless steel, same material as the biopsy needle. No debris has been found on the outer parts of the biopsy needles.
Showing the 5 most recently initiated of 197. Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Status is FDA's own wording; a terminated recall is a closed one, and the total spans the code's whole history, not just what is open today.
Source: openFDA device/recall · retrieved
How many adverse events are reported for HAW?
MAUDE holds 9,295 adverse-event reports naming product code HAW, 1,358 of them received in the last 12 months.
MAUDE reports are submitted by manufacturers, importers, user facilities and the public. They are unverified, and a report is not proof that the device caused the event.
Source: openFDA device/event · retrieved
Is adverse-event reporting in HAW unusual?
One month sits above HAW's own expected range: 1 February 2025.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 131 | Insufficient history | No expected range — too little history | |
| 160 | Insufficient history | No expected range — too little history | |
| 188 | Insufficient history | No expected range — too little history | |
| 174 | Insufficient history | No expected range — too little history | |
| 203 | Insufficient history | No expected range — too little history | |
| 211 | Insufficient history | No expected range — too little history | |
| 196 | Insufficient history | No expected range — too little history | |
| 226 | Insufficient history | No expected range — too little history | |
| 176 | Insufficient history | No expected range — too little history | |
| 371 | Insufficient history | No expected range — too little history | |
| 260 | Insufficient history | No expected range — too little history | |
| 253 | Insufficient history | No expected range — too little history | |
| 203 | Insufficient history | No expected range — too little history | |
| 223 | Insufficient history | No expected range — too little history | |
| 175 | Insufficient history | No expected range — too little history | |
| 281 | Insufficient history | No expected range — too little history | |
| 504 | Insufficient history | No expected range — too little history | |
| 392 | Insufficient history | No expected range — too little history | |
| 445 | Insufficient history | No expected range — too little history | |
| 337 | Insufficient history | No expected range — too little history | |
| 311 | Insufficient history | No expected range — too little history | |
| 305 | 152–478 | Within expected (152–478) | |
| 498 | 133–408 | Above expected (133–408) | |
| 302 | 159–599 | Within expected (159–599) | |
| 296 | 143–591 | Within expected (143–591) | |
| 297 | 124–525 | Within expected (124–525) | |
| 381 | 132–523 | Within expected (132–523) | |
| 264 | 268–815 | Below expected (268–815) | |
| 202 | 119–580 | Within expected (119–580) | |
| 208 | 64–576 | Within expected (64–576) | |
| 220 | 11–558 | Within expected (11–558) | |
| 182 | 0–490 | Within expected (0–490) | |
| 158 | 0–536 | Within expected (0–536) | |
| 163 | 0–609 | Within expected (0–609) | |
| 129 | 0–511 | Within expected (0–511) | |
| 160 | 0–426 | Within expected (0–426) |
21 months do not have a full, unbroken year of history before them, so no expected range is shown for those. Insufficient history is reported as insufficient rather than as zero: an empty baseline would turn a gap in our data into a spike. Method: ewma_alpha_0.3_sd_2 corpus_adjusted. Counts are divided by the corpus-wide volume for that month before comparison, so a rise across all of MAUDE is not reported as a rise in HAW.
Who has entered HAW in the last year?
2 companies filed in HAW for the first time in the last 12 months.
| Company | First cleared | K-number |
|---|---|---|
| Medivis, Inc. | K231897 | |
| Bayer Medical Care, Inc. | K250893 |
"First time" means their first clearance in this product code, not their first ever — an established manufacturer entering a new category is exactly the movement worth knowing about.
Source: openFDA device/510k · retrieved
What are the predicate devices in HAW?
FDA publishes no machine-readable predicate field, so no predicate chain is recorded for this code yet.
A predicate chain matters because a device inherits the safety history of what it was compared to. FDA publishes the chain only inside each 510(k) summary PDF, never as data — so where we have edges, they are read from those documents, and where we do not, we say so instead of showing an empty list.
Who files 510(k)s in HAW?
Across the 423 most recent decisions, these applicants filed most often in HAW.
| Applicant | Recent clearances |
|---|---|
| Brainlab AG | 57 |
| Medtronic Navigation, Inc. | 18 |
| Elekta Instrument AB | 16 |
| Image-Guided Neurologics, Inc. | 15 |
| Surgical Navigation Technologies, Inc. | 15 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
The same makers, after name resolution
2 companies in HAW file under more than one spelling. Resolving them to one identity — across all six datasets, not just this one — is what makes a joined count possible at all.
| Company | Clearances | FDA spellings merged |
|---|---|---|
| Brainlab AG | 59 | 3 |
| Medtronic Navigation, Inc. | 19 | 2 |
Merges are measured against a hand-labelled sample and held above 98% precision; pairs the matcher is unsure of are queued for a person rather than merged. See DeviceSignal.
Source: openFDA device/510k · retrieved
Watch HAW
Get an email the morning anything changes in HAW — a new clearance, a recall, or an adverse-event spike above this code's own baseline.
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Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.