Product code LYC: 510(k) clearances and predicates
Product code LYC covers Cytrans Elashield. FDA lists 231 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
231 clearances on file under product code LYC. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 2 |
| 2023 | 0 |
| 2024 | 0 |
| 2025 | 3 |
| 2026 so far | 3 |
Recent clearances
Newest LYC clearances in the FDA index, with applicant and decision date:
- K253317, Cytrans Elashield, applicant GC America, Inc., decided 2026-07-06. FDA record
- K253883, Bonalive Maxillofacial, applicant Bonalive , Ltd., decided 2026-05-14. FDA record
- K251818, BONTREE PLUS, applicant Hudens Bio Co., Ltd., decided 2026-03-06. FDA record
- K244006, FG Bone Graft M, applicant Full Golden Biotech Co., Ltd., decided 2025-09-17. FDA record
- K243745, FG Bone Graft B, applicant Full Golden Biotech Corporation, decided 2025-08-29. FDA record
- K241186, Synthetic Bone Graft Particulate, applicant Shenzhen Dazhou Medical Technology Co., Ltd., decided 2025-02-21. FDA record
- K213260, CMFlexTM, applicant Dimension Inx Corp., decided 2022-12-30. FDA record
- K202675, InRoad® Dental Synthetic Bone Graft, applicant Osteogene Tech Corp, decided 2022-03-04. 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 Bonalive Maxillofacial, BONTREE PLUS. Watch new LYC 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 LYC?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent LYC clearances include Cytrans Elashield.
How many 510(k) clearances use product code LYC?
231 at the time this page was generated, from openFDA records.
How do I find a predicate device under LYC?
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 LYC clearances?
Get 510(k) alerts filtered to this product code and read each new clearance as it posts.
Get this for LYC, every week.
$49/month. Unlimited codes, one seat covers every client. Cancel anytime.
7-day free trial on the monthly plan. Card required, pay nothing for 7 days. 7-day money-back guarantee. Secure checkout via Stripe.
Not ready? Get one free LYC brief
Tell us where to send it. No card required.
You are on the list.
We will email your free LYC brief shortly. LYC is already in your watchlist draft. Want the ongoing watch instead of one brief? See the 7-day free trial.
Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.