Product code DTB: 510(k) clearances and predicates
Product code DTB covers BIOTRONIK ENDOCARDIAL PACING LEADS. FDA lists 487 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
487 clearances on file under product code DTB. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 0 |
| 2023 | 0 |
| 2024 | 0 |
| 2025 | 0 |
| 2026 so far | 0 |
Recent clearances
Newest DTB clearances in the FDA index, with applicant and decision date:
- K061212, BIOTRONIK ENDOCARDIAL PACING LEADS, applicant Biotronik, Inc., decided 2006-07-10. FDA record
- K041809, PERMANENT PACING LEAD, MODEL PY2, applicant Oscor, Inc., decided 2004-08-06. FDA record
- K040569, PERMANENT PACING LEAD, MODEL REFINO, MODEL: REFINO-R, RU, RJU, applicant Oscor, Inc., decided 2004-04-07. FDA record
- K031274, MODEL 5071 MYOCARDIAL PACING LEAD, applicant Medtronic Vascular, decided 2003-05-22. FDA record
- K031210, MODEL 4951M MYOCARDIAL UNIPOLAR LEAD, applicant Metronic, Inc., decided 2003-05-16. FDA record
- K023205, ELOX P 45-BP; ELOX P 53-BP; ELOX P 60-BP, applicant Biotronik, Inc., decided 2003-04-24. FDA record
- K024053, PERMANENT PACING LEADS, MODELS PHYSIQUE PB AND PJB, applicant Oscor, Inc., decided 2003-01-31. FDA record
- K023803, MODIFICATION TO BIOTRONIK'S STERILIZATION PROCESS, applicant Biotronik, Inc., decided 2002-12-11. 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 PERMANENT PACING LEAD, MODEL PY2, PERMANENT PACING LEAD, MODEL REFINO, MODEL: REFINO-R, RU, RJU. Watch new DTB 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 DTB?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent DTB clearances include BIOTRONIK ENDOCARDIAL PACING LEADS.
How many 510(k) clearances use product code DTB?
487 at the time this page was generated, from openFDA records.
How do I find a predicate device under DTB?
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 DTB clearances?
Get 510(k) alerts filtered to this product code and read each new clearance as it posts.
Get this for DTB, every week.
$49/month. Unlimited codes, one seat covers every client. Cancel anytime.
7-day free trial on the monthly plan. Card required, pay nothing for 7 days. 7-day money-back guarantee. Secure checkout via Stripe.
Not ready? Get one free DTB brief
Tell us where to send it. No card required.
You are on the list.
We will email your free DTB brief shortly. DTB is already in your watchlist draft. Want the ongoing watch instead of one brief? See the 7-day free trial.
Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.