FDA product code · General Hospital
LJTPort & Catheter, Implanted, Subcutaneous, Intravascular
Product code LJT covers Port & Catheter, Implanted, Subcutaneous, Intravascular, a Class II device regulated under 21 CFR 880.5965. FDA has cleared 288 devices in this code, 2 of them in the last 12 months. Median review time across the 288 most recent decisions is 92 days. openFDA lists 141 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 880.5965
- Review panel
- General Hospital
- Clearances
- 288
What is happening in LJT right now?
LJT (Port & Catheter, Implanted, Subcutaneous, Intravascular) has three findings, most consequential first. 1 recall opened in the last 12 months and not yet terminated (Class I) (Z-2395-2026). 1 first-time filer in the last 12 months, Portal Access, Inc (K260916). The code is crowded, scoring 65 of 100 — 79 companies hold a clearance here and 2 arrived in the last 12 months (LJT:crowding).
| Finding | How much it matters | FDA records |
|---|---|---|
| Recall | Class I recall | Z-2395-2026 |
| New entrant | Worth knowing | K260916 |
| Crowding | Context | LJT: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 LJT?
FDA has cleared 288 devices under product code LJT since the 510(k) programme began in 1976, 2 of them in the last 12 months.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260916 | FLEXI-PORT Power Injectable Implantable Port | Portal Access, Inc. | |
| K252478 | Vaccess CT Low-Profile Power-Injectable Implantable Port; Vaccess CT Power-Injectable Implantable Port; PowerPort duo M.R.I. Implantable Port | Bard Access Systems, Inc. | |
| K251253 | PowerPort isp Implantable Port; PowerPort Slim Implantable Port; PowerPort M.R.I. Implantable Port; PowerPort M.R.I. isp Implantable Port | Bard Access Systems, Inc. | |
| K242328 | PowerPort ClearVUE Slim Implantable Ports and PowerPort ClearVUE Slim Implantable Ports | Bard Access Systems, Inc. | |
| K232737 | PowerPort ClearVUE Slim ECG Enabled Implantable Port; PowerPort ClearVUE isp ECG Enabled Implantable Port; PowerPort isp M.R.I. ECG Enabled Implantable Port; PowerPort Slim ECG Enabled Implantable Port | Bard Peripheral Vascular, Inc. | |
| K190559 | SmartPort+ Implantable Ports, SmartPort Plastic Implantable Ports | AngioDynamics, Inc. | |
| K181446 | Bard Power-Injectable Implantable Ports (PowerPorts®) | C.R. Bard, Inc. | |
| K151239 | NMI DUAL PORT II | Navilyst Medical, Inc. | |
| K153359 | BardPort®, SlimPort®, and X-Port® Implanted Ports | C.R. Bard, Inc. | |
| K153238 | Dignity Dual Port | Medcomp ( Medical Components) |
How long does FDA review take for LJT?
The median FDA review time for LJT is 92 days, measured across the 288 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 LJT?
openFDA lists 141 recall records against product code LJT. A recall record covers one firm's corrective action and may span many device lots.
Z-2395-2026Open, ClassifiedArrow International, Inc., Division of Teleflex Medical Inc.
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
Z-2528-2025Open, ClassifiedB.Braun Medical S.A.S.
The potential for minor injury such as damage to the vessel and/or tearing of the vessel wall.
Z-1277-2025Open, ClassifiedSmiths Medical ASD, Inc.
The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
Z-1278-2025Open, ClassifiedSmiths Medical ASD, Inc.
The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
Z-1279-2025Open, ClassifiedSmiths Medical ASD, Inc.
The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
Showing the 5 most recently initiated of 141. 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 LJT?
MAUDE holds 8,017 adverse-event reports naming product code LJT, 3,166 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 LJT unusual?
3 months sit above LJT's own expected range: 1 February 2025, 1 May 2025, 1 June 2025.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 74 | Insufficient history | No expected range — too little history | |
| 55 | Insufficient history | No expected range — too little history | |
| 75 | Insufficient history | No expected range — too little history | |
| 88 | Insufficient history | No expected range — too little history | |
| 162 | Insufficient history | No expected range — too little history | |
| 97 | Insufficient history | No expected range — too little history | |
| 67 | Insufficient history | No expected range — too little history | |
| 120 | Insufficient history | No expected range — too little history | |
| 91 | Insufficient history | No expected range — too little history | |
| 121 | Insufficient history | No expected range — too little history | |
| 125 | Insufficient history | No expected range — too little history | |
| 118 | Insufficient history | No expected range — too little history | |
| 174 | Insufficient history | No expected range — too little history | |
| 147 | Insufficient history | No expected range — too little history | |
| 123 | Insufficient history | No expected range — too little history | |
| 196 | Insufficient history | No expected range — too little history | |
| 133 | Insufficient history | No expected range — too little history | |
| 204 | Insufficient history | No expected range — too little history | |
| 204 | Insufficient history | No expected range — too little history | |
| 207 | Insufficient history | No expected range — too little history | |
| 144 | Insufficient history | No expected range — too little history | |
| 187 | 97–217 | Within expected (97–217) | |
| 246 | 92–197 | Above expected (92–197) | |
| 192 | 106–286 | Within expected (106–286) | |
| 241 | 113–291 | Within expected (113–291) | |
| 305 | 109–291 | Above expected (109–291) | |
| 366 | 119–360 | Above expected (119–360) | |
| 450 | 202–673 | Within expected (202–673) | |
| 373 | 150–515 | Within expected (150–515) | |
| 524 | 180–548 | Within expected (180–548) | |
| 482 | 190–628 | Within expected (190–628) | |
| 430 | 184–593 | Within expected (184–593) | |
| 478 | 215–672 | Within expected (215–672) | |
| 222 | 297–752 | Below expected (297–752) | |
| 311 | 165–572 | Within expected (165–572) | |
| 444 | 158–609 | Within expected (158–609) |
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 LJT.
Who has entered LJT in the last year?
One company filed in LJT for the first time in the last 12 months.
| Company | First cleared | K-number |
|---|---|---|
| Portal Access, Inc. | K260916 |
"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 LJT?
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 LJT?
Across the 288 most recent decisions, these applicants filed most often in LJT.
| Applicant | Recent clearances |
|---|---|
| Strato Medical Corp. | 27 |
| Therex Corp. | 24 |
| C.R. Bard, Inc. | 22 |
| Med Institute, Inc. | 17 |
| Norfolk Medical Products, Inc. | 14 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
Source: openFDA device/510k · retrieved
Watch LJT
Get an email the morning anything changes in LJT — 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.