Product code KKX: 510(k) clearances and predicates
Product code KKX covers BeneHold Surgical Incise Drape with CHG antimicrobial II. FDA lists 450 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
450 clearances on file under product code KKX. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 0 |
| 2023 | 2 |
| 2024 | 0 |
| 2025 | 0 |
| 2026 so far | 0 |
Recent clearances
Newest KKX clearances in the FDA index, with applicant and decision date:
- K230645, BeneHold Surgical Incise Drape with CHG antimicrobial II, applicant Avery Dennison Medical , Ltd., decided 2023-10-25. FDA record
- K222578, 3M Ioban CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG), applicant 3M Company, decided 2023-05-18. FDA record
- K202208, BeneHold Surgical Incise Drape with CHG antimicrobial, applicant Avery Dennison Belgie Bvba, decided 2021-07-30. FDA record
- K200238, ControlRad Sterile Cover, applicant Controlrad, Inc., decided 2020-04-26. FDA record
- K163556, MediClear PreOp, applicant Covalontechnologies, Inc., decided 2017-09-14. FDA record
- K133080, Plus Surgical Drapes (EO Sterilized), PMDB-XXX, applicant Foshan Nanhai Plus Medical Co, Ltd., decided 2015-06-24. FDA record
- K141324, HONGYU DISPOSABLE SURGICAL DRAPES, applicant Weihai Hongyu Nonwoven Fabric Products Co., Ltd., decided 2015-04-14. FDA record
- K140195, SURGICAL DRAPE, applicant Griffith-Lucas, LLC, decided 2014-09-10. 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 3M Ioban CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG), BeneHold Surgical Incise Drape with CHG antimicrobial. Watch new KKX 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 KKX?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent KKX clearances include BeneHold Surgical Incise Drape with CHG antimicrobial II.
How many 510(k) clearances use product code KKX?
450 at the time this page was generated, from openFDA records.
How do I find a predicate device under KKX?
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 KKX clearances?
Get 510(k) alerts filtered to this product code and read each new clearance as it posts.
Get this for KKX, 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 KKX brief
Tell us where to send it. No card required.
You are on the list.
We will email your free KKX brief shortly. KKX 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.