Product code DXY: 510(k) clearances and predicates
Product code DXY covers PIKOS 01, PIKOS E01, PIKOS 01-B, PIKOS E01-B, PIKOS 01-A, PIKOS E01-A. FDA lists 461 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
461 clearances on file under product code DXY. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 0 |
| 2023 | 0 |
| 2024 | 0 |
| 2025 | 0 |
| 2026 so far | 0 |
Recent clearances
Newest DXY clearances in the FDA index, with applicant and decision date:
- K993434, PIKOS 01, PIKOS E01, PIKOS 01-B, PIKOS E01-B, PIKOS 01-A, PIKOS E01-A, applicant Biotronik, Inc., decided 1999-11-10. FDA record
- K970072, OPUS S MODEL 4121 AND 4124 PACEMAKERS, applicant Ela Medical, Inc., decided 1997-08-29. FDA record
- K945627, PIKOS LP 01, PIKOS LP E01, applicant Biotronik, Inc., decided 1996-03-04. FDA record
- K953866, MINIX 834M & MINIX ST 8331M PULSE GENERATORS (MODIFICATION), applicant Medtronic Vascular, decided 1995-12-15. FDA record
- K954092, ALTERNATE STERLIZATION PROCESS & MODIFIED DF-1 LEAD CONNECTOR (MODIFICATION), applicant Medtronic Vascular, decided 1995-12-15. FDA record
- K953417, MINIFLEX MODEL 340, 341, AND 342 PULSE GENERATORS, applicant Cook Pacemaker Corp., decided 1995-09-29. FDA record
- K952328, NANOS, PIKOS 01/E01, 01-A, E01-B, LP 01/LP E01, applicant Biotronik, Inc., decided 1995-09-29. FDA record
- K952364, OPUS PACEMAKERS (MODELS 4001, 4003, 4004, 4023, 4024), applicant Ela Medical, Inc., decided 1995-09-01. 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 OPUS S MODEL 4121 AND 4124 PACEMAKERS, PIKOS LP 01, PIKOS LP E01. Watch new DXY 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 DXY?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent DXY clearances include PIKOS 01, PIKOS E01, PIKOS 01-B, PIKOS E01-B, PIKOS 01-A, PIKOS E01-A.
How many 510(k) clearances use product code DXY?
461 at the time this page was generated, from openFDA records.
How do I find a predicate device under DXY?
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 DXY 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.