FDA product code · Cardiovascular · Class 2
LIT: Catheter, Angioplasty, Peripheral, Transluminal
LIT is FDA's product code for "Catheter, Angioplasty, Peripheral, Transluminal": a Class 2 device classified under 21 CFR 870.1250, reviewed by the Cardiovascular panel.
510(k) review time for LIT
Across 50 510(k) clearances under LIT decided from 2018-01-01 to 2026-10-06, the median was 110 days from FDA receipt to decision. Half took between 53 and 193 days, and 80% were decided within 220 days. These are past clearances, not a forecast for a new submission.
| Fastest | 24 |
|---|---|
| 25th percentile | 53 |
| Median | 110 |
| 75th percentile | 193 |
| 80th percentile | 220 |
| 90th percentile | 260 |
| Slowest | 516 |
| Year | Median days | n |
|---|---|---|
| 2018 | 118 | 6 |
| 2020 | 125 | 9 |
| 2022 | 122 | 8 |
| 2023 | 167 | 6 |
| 2024 | 43 | 6 |
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.
LIT in the public FDA record
| 510(k) clearances, all years | 403 |
|---|---|
| Device recalls | 32 |
| Establishment listings | 413 |
| GUDID device identifiers | 18,658 |
Counts of records, not of devices or events. Adverse event reports for LIT 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 LIT
5 FDA recognized consensus standards cite LIT, among them AAMI TIR42:2021; ISO 18193 First edition 2021-08; ISO 11658 First edition 2012-05-15. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.
- 3-172 AAMI TIR42:2021 — Evaluation of Particulates Associated with Vascular Medical Devices
- 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
- 6-498 ISO 10555-4 Third edition 2023-11 — Intravascular catheters - Sterile and single-use catheters - Part 4: Balloon dilatation catheters
- 6-499 ISO 10555-1 Third edition 2023-11 — Intravascular catheters - Sterile and single-use intravascular catheters - Part 1: General requirements
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.