FDA product code LJS: Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
LJS is the FDA product code for catheter, intravascular, therapeutic, long-term greater than 30 days. It is a Class II device, regulated under 21 CFR 880.5970 and reviewed by the General Hospital panel. FDA has cleared 302 510(k) submissions under LJS, 17 in the last five years, from 109 different applicants. The average 510(k) review took 131 days (median 90); 129 days on average over the last three years. FDA has posted 324 recalls for LJS devices, 11 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days |
| Device class | Class II |
| Regulation | 21 CFR 880.5970 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for LJS
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 7 | 121 |
| 2018 | 10 | 147 |
| 2020 | 2 | 184 |
| 2021 | 3 | 281 |
| 2022 | 3 | 134 |
| 2023 | 4 | 97 |
| 2024 | 1 | 201 |
| 2025 | 8 | 157 |
| 2026 | 1 | 28 |
Compare with all 510(k) review times · Search every LJS clearance
Top LJS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| C.R. Bard, Inc. | 34 | 2021-03-12 |
| Navilyst Medical, Inc. | 16 | 2017-02-03 |
| Medcomp | 11 | 2010-12-21 |
| AngioDynamics, Inc. | 10 | 2015-01-27 |
| Vygon Corp. | 10 | 2006-09-15 |
104 more applicants have LJS clearances. See the full list in Caduvo.
Most recent LJS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K260929 | Navi Medical Technologies | Neonav ECG Tip Location System | 2026-04-17 | 28 |
| K252373 | Spectrum Vascular | 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 | 2025-12-16 | 139 |
| K252792 | Piccolo Medical, Inc. | PM2 System with ECGuide Connector | 2025-11-17 | 76 |
| K243458 | Access Vascular, Inc. | 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 | 2025-08-01 | 266 |
| K251212 | Access Vascular, Inc. | Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM) (PICC-251CM); Dual Lumen 5Fr HydroPICC Catheter (PICC-252CM) (PICC-252CM) | 2025-07-01 | 74 |
Recalls for LJS devices
324 product recalls in 75 recall events; 11 initiated in the last five years and 11 still open. Most recent: 2025-12-12.
| Year | Recalls |
|---|---|
| 2017 | 15 |
| 2018 | 53 |
| 2019 | 37 |
| 2020 | 10 |
| 2021 | 21 |
| 2023 | 8 |
| 2024 | 1 |
| 2025 | 2 |
Frequently asked questions
What is FDA product code LJS?
LJS is the FDA product code for catheter, intravascular, therapeutic, long-term greater than 30 days. It is a Class II device, regulated under 21 CFR 880.5970 and reviewed by the General Hospital panel.
What device class is LJS?
Class II, regulation 21 CFR 880.5970. Typical premarket route: 510(k).
How long does a 510(k) take for product code LJS?
Across 302 cleared submissions the average was 131 days from receipt to decision (median 90).
Which companies have the most LJS clearances?
C.R. Bard, Inc. (34); Navilyst Medical, Inc. (16); Medcomp (11); AngioDynamics, Inc. (10); Vygon Corp. (10).
Have LJS devices been recalled?
Yes: 324 product recalls across 75 recall events; the most recent began 2025-12-12.
Next steps
- Run an FDA pathway report with predicate devices for product code LJS
- Run a recall and safety report across every LJS manufacturer
- Watch product code LJS for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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