Product code DRX: 510(k) clearances and predicates
Product code DRX covers Physiotrace. FDA lists 329 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
329 clearances on file under product code DRX. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 0 |
| 2023 | 0 |
| 2024 | 0 |
| 2025 | 0 |
| 2026 so far | 0 |
Recent clearances
Newest DRX clearances in the FDA index, with applicant and decision date:
- K171244, Physiotrace, applicant Nimbleheart, Inc., decided 2017-08-23. FDA record
- K140096, HMICRO WIRED C-PATCH ELECTRODE, TRADE NAME SUBJECT TO CHANGE, applicant Hmicro, Inc., decided 2014-07-24. FDA record
- K123658, BIOMODULE 3-M1, applicant Zephyr Technology Corporation, decided 2013-04-24. FDA record
- K101576, CENTERRIDGE DIAGNOSTIC ECG ELECTRODE, CENTERRIDGE MONITORING ECG ELECTRODES, applicant Team Innovations, Inc., decided 2010-07-22. FDA record
- K101685, IP-SET, applicant Integral Process Sas, decided 2010-07-01. FDA record
- K100129, AMBU BLUE SENSOR NEO, AMBU BLUE SENSOR NEO X, applicant Ambu A/S, decided 2010-06-11. FDA record
- K093327, INTCO TAB ELECTRODE, applicant Shanghai Intco Electrode Manufacturing Co., Ltd., decided 2010-05-10. FDA record
- K100315, 12 LEAD GLOVE, applicant I Needmd, Inc., decided 2010-04-23. 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 HMICRO WIRED C-PATCH ELECTRODE, TRADE NAME SUBJECT TO CHANGE, BIOMODULE 3-M1. Watch new DRX 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 DRX?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent DRX clearances include Physiotrace.
How many 510(k) clearances use product code DRX?
329 at the time this page was generated, from openFDA records.
How do I find a predicate device under DRX?
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 DRX clearances?
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Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.