Product code LIT: 510(k) clearances and predicates
Product code LIT covers Amethyst HP PTA OTW 0.035 Catheter. FDA lists 405 clearances under this code in the 510(k) index. This page summarizes recent clearance volume and names recent clearances by K number so you can pick predicates faster.
Clearance volume
405 clearances on file under product code LIT. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 8 |
| 2023 | 6 |
| 2024 | 6 |
| 2025 | 3 |
| 2026 so far | 4 |
Recent clearances
Newest LIT clearances in the FDA index, with applicant and decision date:
- K260416, ZYLOX Hippo PTA Balloon Dilatation Catheter, applicant Zylox Medtech Co., Ltd., decided 2026-09-21. FDA record
- K254212, NC PTA Balloon Dilatation Catheter, applicant Kossel Medtech (Suzhou) Co., Ltd., decided 2026-09-16. FDA record
- K260304, WAVE PTA Balloon Catheter, applicant WAVE Medical AG, decided 2026-05-20. FDA record
- K252512, Armada 14 NC PTA Catheter, applicant ABBOTT MEDICAL, decided 2026-02-13. FDA record
- K251915, Amethyst HP PTA OTW 0.035 Catheter, applicant Natec Medical , Ltd., decided 2025-12-18. FDA record
- K250706, Passeo-35 Xeo Peripheral Dilatation Catheter; Passeo-18 Peripheral Dilatation Catheters; Passeo-14 Peripheral Dilatation Catheter; Oscar Peripheral Multifunctional Catheter System; Pantera Pro Percutaneous Transluminal Coronary Angioplasty Catheter; Pantera LEO Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter, applicant Biotronik, Inc., decided 2025-04-04. FDA record
- K243704, Parafleet SC 014 PTA Balloon Dilatation Catheter; Parafleet SC 018 PTA Balloon Dilatation Catheter; Parafleet SC 035 PTA Balloon Dilatation Catheter, applicant Brosmed Medical Co., Ltd., decided 2025-02-27. FDA record
- K241040, Amethyst HP PTA OTW 0.035 Catheter, applicant Natec Medical , Ltd., decided 2024-12-18. FDA record
What this means for a regulatory watcher
Volume tells you how deep the predicate pool is. A code with steady yearly counts gives you many candidate predicates, which helps when one predicate has a recall or design gap. A code with a sharp recent rise means reviewers are seeing more of this device type, so substantial equivalence arguments need to track the newest cleared devices, not five year old ones. Related device names in recent clearances include ZYLOX Hippo PTA Balloon Dilatation Catheter, NC PTA Balloon Dilatation Catheter. Watch new LIT clearances as they post: each one is a possible predicate for your submission and a possible competitor worth reading.
FAQ
What is FDA product code LIT?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent LIT clearances include Amethyst HP PTA OTW 0.035 Catheter.
How many 510(k) clearances use product code LIT?
405 at the time this page was generated, from openFDA records.
How do I find a predicate device under LIT?
Start with the recent K numbers listed above, then run the free predicate search to check substantial equivalence text and review history.
How do I track new LIT clearances?
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Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.