FDA product code · General Hospital · Class 2
LJS: Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
LJS is FDA's product code for "Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days": a Class 2 device classified under 21 CFR 880.5970, reviewed by the General Hospital panel. FDA flags it as an implant.
510(k) review time for LJS
Across 32 510(k) clearances under LJS decided from 2018-01-01 to 2026-10-06, the median was 155 days from FDA receipt to decision. Half took between 70 and 236 days, and 80% were decided within 252 days. These are past clearances, not a forecast for a new submission.
| Fastest | 28 |
|---|---|
| 25th percentile | 70 |
| Median | 155 |
| 75th percentile | 236 |
| 80th percentile | 252 |
| 90th percentile | 266 |
| Slowest | 380 |
| Year | Median days | n |
|---|---|---|
| 2018 | 148 | 10 |
| 2025 | 171 | 8 |
Source: openFDA 510(k) records, snapshot of 2026-10-06 (openFDA data as of 2026-09-28). Compare 510(k) review times across all device types, see every code side by side in the Clearance Timeline Estimator, or browse the clearances themselves in PredicateScope.
LJS in the public FDA record
| 510(k) clearances, all years | 302 |
|---|---|
| Device recalls | 332 |
| Establishment listings | 558 |
| GUDID device identifiers | 5,601 |
Counts of records, not of devices or events. Adverse event reports for LJS are in MAUDEScope, as counts with the query shown: MAUDE has no denominator, so a report count is not a rate and does not show that a device caused an event.
FDA-recognized standards that cite LJS
6 FDA recognized consensus standards cite LJS, among them ISO 18193 First edition 2021-08; ISO 11658 First edition 2012-05-15; ISO 23908 First edition 2011-06-11. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.
- 3-176 ISO 18193 First edition 2021-08 — Cardiovascular implants and artificial organs - Cannulae for extracorporeal circulation
- 3-183 ISO 11658 First edition 2012-05-15 — Cardiovascular implants and extracorporeal systems - Blood/tissue contact surface modifications for extracorporeal perfusion systems
- 6-273 ISO 23908 First edition 2011-06-11 — Sharps injury protection - Requirements and test methods - Sharps protection features for single-use hypodermic needles introducers for catheters and needles used for blood sampling
- 6-305 ISO 10555-3 Second edition 2013-06-15 — Intravascular catheters -- Sterile and single-use catheters -- Part 3: Central venous catheters
- 6-499 ISO 10555-1 Third edition 2023-11 — Intravascular catheters - Sterile and single-use intravascular catheters - Part 1: General requirements
- 6-507 ISO 23908 Second Edition 2024-12 — Sharps injury protection - Sharps protection mechanisms for single-use needles introducers for catheters and needles used for blood testing monitoring sampling and medical substance administration - Requirements and test methods
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.