Product code KNX: 510(k) clearances and predicates
Product code KNX covers IBAG. FDA lists 206 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
206 clearances on file under product code KNX. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 0 |
| 2023 | 0 |
| 2024 | 0 |
| 2025 | 0 |
| 2026 so far | 0 |
Recent clearances
Newest KNX clearances in the FDA index, with applicant and decision date:
- K110518, IBAG, applicant Future Path Medical, LLC, decided 2011-06-24. FDA record
- K973364, 4L DRAINAGE BAG, 4L BAG FOR PERITONEAL DIALYSIS, 4L URINARY DRAINAGE BAG, applicant Maersk Medical A/S, decided 1998-03-17. FDA record
- K972887, MEDLINE PREMIUM LEG BAG, MEDLINE FABRIC BAC LEG BAG, MEDLINE URINARY LEG BAG, applicant Medline Industries, Inc., decided 1997-12-11. FDA record
- K971271, BESECURE EXTERNAL URINARY COLLECTION SYSTEM, applicant Urology Research Intl., Inc., decided 1997-08-18. FDA record
- K971929, AMSINO URINARY LEG BAG, applicant Amsino Intl., Inc., decided 1997-08-06. FDA record
- K971764, WELCON HUE-VU URINARY DRAINAGE BAG, applicant Welcon, Inc., decided 1997-07-29. FDA record
- K964690, LIBERTY VALVE, applicant Cleveland Medical Devices, Inc., decided 1997-03-21. FDA record
- K964745, AMSINO URINARY DRAINAGE BAG, applicant Amsino Intl., Inc., decided 1997-03-18. 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 4L DRAINAGE BAG, 4L BAG FOR PERITONEAL DIALYSIS, 4L URINARY DRAINAGE BAG, MEDLINE PREMIUM LEG BAG, MEDLINE FABRIC BAC LEG BAG, MEDLINE URINARY LEG BAG. Watch new KNX 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 KNX?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent KNX clearances include IBAG.
How many 510(k) clearances use product code KNX?
206 at the time this page was generated, from openFDA records.
How do I find a predicate device under KNX?
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 KNX clearances?
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Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.