Product code DRG: 510(k) clearances and predicates
Product code DRG covers UbiqVue 2AYe Cardiac System (UX2253). FDA lists 192 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
192 clearances on file under product code DRG. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 6 |
| 2023 | 4 |
| 2024 | 3 |
| 2025 | 3 |
| 2026 so far | 2 |
Recent clearances
Newest DRG clearances in the FDA index, with applicant and decision date:
- K261569, UbiqVue 2AYe Cardiac System (UX2253), applicant Lifesignals, Inc., decided 2026-07-09. FDA record
- K252984, Perin Health System (PHD80060-2), applicant Perin Health Devices, LLC, decided 2026-01-22. FDA record
- K252440, EasyTeleMed (2.0.2), applicant Ingeniars S.R.L., decided 2025-10-02. FDA record
- K250259, TeleRehab Aermos Cardiopulmonary Rehabilitation, applicant The ScottCare Corporation, decided 2025-06-04. FDA record
- K243837, iBSM, applicant Iorbit Digital Technologies Private Limited, decided 2025-05-16. FDA record
- K242018, UbiqVue 2A Multi-parameter System (UX2550), applicant Lifesignals, Inc., decided 2024-11-12. FDA record
- K241101, BioButton System, applicant Biointellisense, Inc., decided 2024-09-26. FDA record
- K240251, ANNE Chest, applicant Sibel Health, Inc., decided 2024-06-03. 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 Perin Health System (PHD80060-2), EasyTeleMed (2.0.2). Watch new DRG 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 DRG?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent DRG clearances include UbiqVue 2AYe Cardiac System (UX2253).
How many 510(k) clearances use product code DRG?
192 at the time this page was generated, from openFDA records.
How do I find a predicate device under DRG?
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 DRG clearances?
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Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.