FDA product code · Neurology
JXGShunt, Central Nervous System And Components
Product code JXG covers Shunt, Central Nervous System And Components, a Class II device regulated under 21 CFR 882.5550. FDA has cleared 259 devices in this code, 4 of them in the last 12 months. Median review time across the 259 most recent decisions is 89 days. openFDA lists 108 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 882.5550
- Review panel
- Neurology
- Clearances
- 259
What is happening in JXG right now?
JXG (Shunt, Central Nervous System And Components) has three findings, most consequential first. 1 recall opened in the last 12 months and not yet terminated (Class II) (Z-2173-2026). 1 first-time filer in the last 12 months, Brainspace, Inc (K251598). The code is crowded, scoring 64 of 100 — 55 companies hold a clearance here and 4 arrived in the last 12 months (JXG:crowding).
| Finding | How much it matters | FDA records |
|---|---|---|
| Recall | Class II recall | Z-2173-2026 |
| New entrant | Worth knowing | K251598 |
| Crowding | Context | JXG: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 JXG?
FDA has cleared 259 devices under product code JXG since the 510(k) programme began in 1976, 4 of them in the last 12 months.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261004 | Codman® Distal Peritoneal Catheter, Barium Open End (82-1682); Codman® HOLTER® Peritoneal Catheter (SALMON Design) (82-1684) | Integra Lifesciences Production Corporation | |
| K251598 | Intellidrop | Brainspace, Inc. | |
| K250636 | Sophy Mini Monopressure Valve (SM1) | Sophysa | |
| K252514 | EVAC-MRI | Phasor Health, LLC | |
| K243531 | Codman Libertís Shunt Catheter with Bactiseal and Endexo Technology | Integra Lifesciences Production Corporation | |
| K243552 | Codman Libertís 1.5 mm EVD Catheter with Bactiseal® and Endexo® Technology with Luer Connection (821761); Codman Libertís 1.9 mm EVD Catheter with Bactiseal® and Endexo® Technology with Luer Connection (821762) | Integra Lifesciences Production Corporation | |
| K242974 | External CSF Drainage Ventricular Catheters, External CSF Drainage Lumbar Catheters | Sophysa | |
| K243205 | EVAC | Phasor Health, LLC | |
| K243676 | Duet External Drainage and Monitoring System (EDMS) | Medtronic Neurosurgery | |
| K242003 | XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter Set | Aesculap, Inc. |
How long does FDA review take for JXG?
The median FDA review time for JXG is 89 days, measured across the 259 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 JXG?
openFDA lists 108 recall records against product code JXG. A recall record covers one firm's corrective action and may span many device lots.
Z-2173-2026Open, ClassifiedIntegra LifeSciences Corp. (NeuroSciences)
Out-of-specification endotoxin result that did not meet the acceptance criteria.
Z-0977-2025Open, ClassifiedIntegra LifeSciences Corporation
Potential for certain SKUs and lot numbers were distributed with the incorrect product description on the internal and external labels.
Z-0978-2025Open, ClassifiedIntegra LifeSciences Corporation
Potential for certain SKUs and lot numbers were distributed with the incorrect product description on the internal and external labels.
Z-0979-2025Open, ClassifiedIntegra LifeSciences Corporation
Potential for certain SKUs and lot numbers were distributed with the incorrect product description on the internal and external labels.
Z-2136-2024Open, ClassifiedIntegra LifeSciences Corporation
Defect in the external sterile packaging (pouch) leading to a gap or/and weakness of the seal that may compromise the product sterility.
Showing the 5 most recently initiated of 108. 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 JXG?
MAUDE holds 3,603 adverse-event reports naming product code JXG, 783 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 JXG unusual?
One month sits above JXG's own expected range: 1 June 2025.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 88 | Insufficient history | No expected range — too little history | |
| 102 | Insufficient history | No expected range — too little history | |
| 79 | Insufficient history | No expected range — too little history | |
| 85 | Insufficient history | No expected range — too little history | |
| 116 | Insufficient history | No expected range — too little history | |
| 101 | Insufficient history | No expected range — too little history | |
| 94 | Insufficient history | No expected range — too little history | |
| 119 | Insufficient history | No expected range — too little history | |
| 96 | Insufficient history | No expected range — too little history | |
| 80 | Insufficient history | No expected range — too little history | |
| 103 | Insufficient history | No expected range — too little history | |
| 81 | Insufficient history | No expected range — too little history | |
| 92 | Insufficient history | No expected range — too little history | |
| 108 | Insufficient history | No expected range — too little history | |
| 82 | Insufficient history | No expected range — too little history | |
| 99 | Insufficient history | No expected range — too little history | |
| 107 | Insufficient history | No expected range — too little history | |
| 120 | Insufficient history | No expected range — too little history | |
| 112 | Insufficient history | No expected range — too little history | |
| 120 | Insufficient history | No expected range — too little history | |
| 110 | Insufficient history | No expected range — too little history | |
| 74 | 79–122 | Below expected (79–122) | |
| 73 | 61–100 | Within expected (61–100) | |
| 80 | 65–110 | Within expected (65–110) | |
| 98 | 65–111 | Within expected (65–111) | |
| 105 | 64–107 | Within expected (64–107) | |
| 124 | 70–119 | Above expected (70–119) | |
| 109 | 116–209 | Below expected (116–209) | |
| 111 | 72–150 | Within expected (72–150) | |
| 79 | 76–158 | Within expected (76–158) | |
| 116 | 60–149 | Within expected (60–149) | |
| 107 | 57–138 | Within expected (57–138) | |
| 107 | 68–154 | Within expected (68–154) | |
| 92 | 77–175 | Within expected (77–175) | |
| 87 | 55–142 | Within expected (55–142) | |
| 108 | 55–153 | Within expected (55–153) |
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 JXG.
Who has entered JXG in the last year?
One company filed in JXG for the first time in the last 12 months.
| Company | First cleared | K-number |
|---|---|---|
| Brainspace, Inc. | K251598 |
"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 JXG?
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 JXG?
Across the 259 most recent decisions, these applicants filed most often in JXG.
| Applicant | Recent clearances |
|---|---|
| Codman & Shurtleff, Inc. | 23 |
| Holter-Hausner Intl. | 21 |
| Cordis Corp. | 18 |
| Medtronic Neurosurgery | 18 |
| Pudenz-Schulte Medical Research Corp. | 18 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
Source: openFDA device/510k · retrieved
Watch JXG
Get an email the morning anything changes in JXG — 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.