FDA product code · General Hospital
LJSCatheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Product code LJS covers Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days, a Class II device regulated under 21 CFR 880.5970. FDA has cleared 302 devices in this code, 3 of them in the last 12 months. Median review time across the 302 most recent decisions is 90 days. openFDA lists 332 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 880.5970
- Review panel
- General Hospital
- Clearances
- 302
What is happening in LJS right now?
LJS (Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days) has three findings, most consequential first. 5 recalls opened in the last 12 months and not yet terminated (Class II) (Z-2803-2026, Z-2804-2026, Z-2658-2026, Z-2659-2026, Z-2664-2026). 1 first-time filer in the last 12 months, Spectrum Vascular (K252373). The code is crowded, scoring 69 of 100 — 97 companies hold a clearance here and 3 arrived in the last 12 months (LJS:crowding).
| Finding | How much it matters | FDA records |
|---|---|---|
| Recall | Class II recall | Z-2803-2026, Z-2804-2026, Z-2658-2026, Z-2659-2026, Z-2664-2026 |
| New entrant | Worth knowing | K252373 |
| Crowding | Context | LJS: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 LJS?
FDA has cleared 302 devices under product code LJS since the 510(k) programme began in 1976, 3 of them in the last 12 months.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260929 | Neonav ECG Tip Location System | Navi Medical Technologies | |
| K252373 | BioFlo Hybrid PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology; BioFlo Midline Catheter; Xcela Power Injectable PICC; Xcela PICC with PASV Valve Technology; Xcela Hybrid PICC with PASV Valve Technology | Spectrum Vascular | |
| K252792 | PM2 System with ECGuide Connector | Piccolo Medical, Inc. | |
| K243458 | HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001301); HydroPICC 4Fr Single Lumen Marked catheter, 70 cm guidewire - Basic Kit (70001302); HydroPICC 4Fr Single Lumen Marked catheter - Maximal Barrier kit (70001304); HydroPICC 5Fr Dual Lumen Marked catheter, 130 cm guidewire - Basic Kit (70002301); HydroPICC 5Fr Dual Lumen Marked catheter, 70 cm guidewire - Basic Kit (70002302); HydroPICC 5Fr Dual Lumen Marked catheter - Maximal Barrier kit (70002304); Hydr | Access Vascular, Inc. | |
| K251212 | Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM) (PICC-251CM); Dual Lumen 5Fr HydroPICC Catheter (PICC-252CM) (PICC-252CM) | Access Vascular, Inc. | |
| K243484 | PM2+ System and SmartPICC Stylet | Piccolo Medical, Inc. | |
| K241587 | pilot TLS | Vygon Corporation | |
| K241910 | Neonav ECG Tip Location System | Navi Medical Technologies | |
| K243941 | HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001201); HydroPICC 4Fr Single Lumen Marked catheter, 70 cm guidewire - Basic Kit (70001202); HydroPICC 4Fr Single Lumen Marked catheter, Maximal Barrier kit (70001204); HydroPICC 4Fr Single Lumen Marked catheter, Mobile Maximal Barrier Kit (90001204) | Access Vascular, Inc. | |
| K240486 | PM2 System and ECGuide Connector | Piccolo Medical, Inc. |
How long does FDA review take for LJS?
The median FDA review time for LJS is 90 days, measured across the 302 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 LJS?
openFDA lists 332 recall records against product code LJS. A recall record covers one firm's corrective action and may span many device lots.
Z-2803-2026Open, ClassifiedArgon Medical Devices, Inc
Catheters, indicated for short/long-term peripheral access to central venous system for the administration of fluids, medications, nutrients; and sampling, may experience leaking and/or cracking at the hub, which may lead to replacement, inability to flush/aspirate catheter, catheter occlusion, therapy interruption, blood loss, tissue irritation, bloodstream infection.
Z-2804-2026Open, ClassifiedArgon Medical Devices, Inc
Catheters, indicated for short/long-term peripheral access to central venous system for the administration of fluids, medications, nutrients; and sampling, may experience leaking and/or cracking at the hub, which may lead to replacement, inability to flush/aspirate catheter, catheter occlusion, therapy interruption, blood loss, tissue irritation, bloodstream infection.
Z-2658-2026Open, ClassifiedBard Access Systems, Inc.
Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
Z-2659-2026Open, ClassifiedBard Access Systems, Inc.
Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
Z-2664-2026Open, ClassifiedBard Access Systems, Inc.
Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
Showing the 5 most recently initiated of 332. 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 LJS?
MAUDE holds 11,493 adverse-event reports naming product code LJS, 2,431 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 LJS unusual?
Every month with enough history behind it falls inside LJS's own expected range. Nothing here is unusual for this code.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 158 | Insufficient history | No expected range — too little history | |
| 143 | Insufficient history | No expected range — too little history | |
| 236 | Insufficient history | No expected range — too little history | |
| 238 | Insufficient history | No expected range — too little history | |
| 215 | Insufficient history | No expected range — too little history | |
| 282 | Insufficient history | No expected range — too little history | |
| 247 | Insufficient history | No expected range — too little history | |
| 282 | Insufficient history | No expected range — too little history | |
| 223 | Insufficient history | No expected range — too little history | |
| 234 | Insufficient history | No expected range — too little history | |
| 267 | Insufficient history | No expected range — too little history | |
| 289 | Insufficient history | No expected range — too little history | |
| 267 | Insufficient history | No expected range — too little history | |
| 325 | Insufficient history | No expected range — too little history | |
| 360 | Insufficient history | No expected range — too little history | |
| 385 | Insufficient history | No expected range — too little history | |
| 391 | Insufficient history | No expected range — too little history | |
| 329 | Insufficient history | No expected range — too little history | |
| 452 | Insufficient history | No expected range — too little history | |
| 425 | Insufficient history | No expected range — too little history | |
| 519 | Insufficient history | No expected range — too little history | |
| 402 | 254–522 | Within expected (254–522) | |
| 403 | 236–448 | Within expected (236–448) | |
| 326 | 280–527 | Within expected (280–527) | |
| 377 | 272–514 | Within expected (272–514) | |
| 349 | 265–464 | Within expected (265–464) | |
| 312 | 280–468 | Within expected (280–468) | |
| 435 | 401–715 | Within expected (401–715) | |
| 353 | 262–526 | Within expected (262–526) | |
| 325 | 254–547 | Within expected (254–547) | |
| 303 | 220–534 | Within expected (220–534) | |
| 323 | 163–477 | Within expected (163–477) | |
| 336 | 181–532 | Within expected (181–532) | |
| 289 | 225–581 | Within expected (225–581) | |
| 337 | 153–473 | Within expected (153–473) | |
| 238 | 224–474 | Within expected (224–474) |
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 LJS.
Who has entered LJS in the last year?
One company filed in LJS for the first time in the last 12 months.
| Company | First cleared | K-number |
|---|---|---|
| Spectrum Vascular | K252373 |
"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 LJS?
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 LJS?
Across the 302 most recent decisions, these applicants filed most often in LJS.
| Applicant | Recent clearances |
|---|---|
| C.R. Bard, Inc. | 34 |
| Navilyst Medical, Inc. | 16 |
| Medcomp | 11 |
| AngioDynamics, Inc. | 10 |
| Vygon Corp. | 10 |
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 LJS 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 |
|---|---|---|
| Arrow International, Inc., Division of Teleflex Medical Inc. | 15 | 6 |
| Medical Components, Inc dba MedComp | 11 | 3 |
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 LJS
Get an email the morning anything changes in LJS — 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.