Product code GXY: 510(k) clearances and predicates
Product code GXY covers Dexus Prosthetic System (MSL2, MSR2). FDA lists 440 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
440 clearances on file under product code GXY. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 5 |
| 2023 | 13 |
| 2024 | 7 |
| 2025 | 6 |
| 2026 so far | 11 |
Recent clearances
Newest GXY clearances in the FDA index, with applicant and decision date:
- K262654, Dexus Prosthetic System (MSL2, MSR2), applicant Zhejiang Qiangnao Technology Co.,Ltd, decided 2026-08-27. FDA record
- K260578, Ambu® NeurolineTM Cup MRI/CT (Models 72704/21US, 72704/23US, 72704/25US, 72704/27US) Ambu® NeurolineTM Cup MRI/CT-set (Models 72704/21-1010US, 72704/21-1010US, 72704/23-1010US, 72704/25-1010US, 72704/27-1010US) Ambu® NeurolineTM Cup MRI/CT-mini set (Models 72704/21-0301US, 72704/23-0301US, 72704/25-0301US, 72704/27-0301US), applicant Ambu A/S, decided 2026-07-14. FDA record
- K261442, Charlotte ACC25 Surface Electrode Array; Charlotte ACC25 Reusable Surface Electrode Array, applicant Cadwell Industries, Inc., decided 2026-06-26. FDA record
- K261522, BioWave BioWraps, applicant Biowave Corporation, decided 2026-06-03. FDA record
- K253237, Elde Medical Electrodes (T5/ 5 cm x 5cm electrode T10/ 5 cm x 10cm electrode), applicant Elde Medikal Sanayi ve Ticaret Anonim Sirketi, decided 2026-05-08. FDA record
- K254183, MR Conditional Cup Electrodes, applicant Technomed Europe, decided 2026-05-07. FDA record
- K252439, Tutamen Self Adhesive Electrodes, applicant Dongguan Tutamen Metalwork Co., Ltd., decided 2026-05-01. FDA record
- K253256, myosmart. (13E522); myosmart.cuff (757M20-2); connectgrip. (560X27-1); myosmart trial kit (642V64=T), applicant Otto Bock Healthcare Products GmbH, decided 2026-04-22. 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 Ambu® NeurolineTM Cup MRI/CT (Models 72704/21US, 72704/23US, 72704/25US, 72704/27US) Ambu® NeurolineTM Cup MRI/CT-set (Models 72704/21-1010US, 72704/21-1010US, 72704/23-1010US, 72704/25-1010US, 72704/27-1010US) Ambu® NeurolineTM Cup MRI/CT-mini set (Models 72704/21-0301US, 72704/23-0301US, 72704/25-0301US, 72704/27-0301US), Charlotte ACC25 Surface Electrode Array; Charlotte ACC25 Reusable Surface Electrode Array. Watch new GXY 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 GXY?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent GXY clearances include Dexus Prosthetic System (MSL2, MSR2).
How many 510(k) clearances use product code GXY?
440 at the time this page was generated, from openFDA records.
How do I find a predicate device under GXY?
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 GXY clearances?
Get 510(k) alerts filtered to this product code and read each new clearance as it posts.
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Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.