FDA product code LJT: Port & Catheter, Implanted, Subcutaneous, Intravascular
LJT is the FDA product code for port & catheter, implanted, subcutaneous, intravascular. It is a Class II device, regulated under 21 CFR 880.5965 and reviewed by the General Hospital panel. FDA has cleared 288 510(k) submissions under LJT, 5 in the last five years, from 80 different applicants. The average 510(k) review took 131 days (median 94); 73 days on average over the last three years. FDA has posted 141 recalls for LJT devices, 15 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Port & Catheter, Implanted, Subcutaneous, Intravascular |
| Device class | Class II |
| Regulation | 21 CFR 880.5965 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for LJT
| Year | Clearances | Avg. review days |
|---|---|---|
| 2019 | 1 | 402 |
| 2020 | 1 | 444 |
| 2023 | 1 | 92 |
| 2024 | 1 | 86 |
| 2025 | 2 | 42 |
| 2026 | 1 | 90 |
Compare with all 510(k) review times · Search every LJT clearance
Top LJT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Strato Medical Corp. | 27 | 1995-02-01 |
| Therex Corp. | 24 | 1995-09-13 |
| C.R. Bard, Inc. | 22 | 2019-07-08 |
| Med Institute, Inc. | 17 | 1998-09-16 |
| Norfolk Medical Products, Inc. | 14 | 2011-10-27 |
75 more applicants have LJT clearances. See the full list in Caduvo.
Most recent LJT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K260916 | Portal Access, Inc. | FLEXI-PORT Power Injectable Implantable Port | 2026-06-17 | 90 |
| K252478 | Bard Access Systems, Inc. | Vaccess CT Low-Profile Power-Injectable Implantable Port; Vaccess CT Power-Injectable Implantable Port; PowerPort duo M.R.I. Implantable Port | 2025-09-05 | 29 |
| K251253 | Bard Access Systems, Inc. | PowerPort isp Implantable Port; PowerPort Slim Implantable Port; PowerPort M.R.I. Implantable Port; PowerPort M.R.I. isp Implantable Port | 2025-06-18 | 56 |
| K242328 | Bard Access Systems, Inc. | PowerPort ClearVUE Slim Implantable Ports and PowerPort ClearVUE Slim Implantable Ports | 2024-10-31 | 86 |
| K232737 | Bard Peripheral Vascular, Inc. | 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 | 2023-12-08 | 92 |
Recalls for LJT devices
141 product recalls in 47 recall events; 15 initiated in the last five years and 18 still open. Most recent: 2026-04-21.
| Year | Recalls |
|---|---|
| 2017 | 6 |
| 2018 | 16 |
| 2019 | 17 |
| 2020 | 2 |
| 2021 | 5 |
| 2022 | 1 |
| 2025 | 13 |
| 2026 | 1 |
Frequently asked questions
What is FDA product code LJT?
LJT is the FDA product code for port & catheter, implanted, subcutaneous, intravascular. It is a Class II device, regulated under 21 CFR 880.5965 and reviewed by the General Hospital panel.
What device class is LJT?
Class II, regulation 21 CFR 880.5965. Typical premarket route: 510(k).
How long does a 510(k) take for product code LJT?
Across 288 cleared submissions the average was 131 days from receipt to decision (median 94).
Which companies have the most LJT clearances?
Strato Medical Corp. (27); Therex Corp. (24); C.R. Bard, Inc. (22); Med Institute, Inc. (17); Norfolk Medical Products, Inc. (14).
Have LJT devices been recalled?
Yes: 141 product recalls across 47 recall events; the most recent began 2026-04-21.
Next steps
- Run an FDA pathway report with predicate devices for product code LJT
- Run a recall and safety report across every LJT manufacturer
- Watch product code LJT 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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