Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Biotronik, GmbH & Co. — Predicate Candidate Screening
18 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
148 daysmedian FDA review time
422 days90th percentile
18clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K000763 | PX 53/15-BP, MODEL 130 050 AND PX 60/15-BP, MODEL 130 051 | Biotronik, GmbH & Co. | 2000-04-06 | 28 | 0 |
| K923406 | BIOSCOPE | Biotronik, GmbH & Co. | 1993-09-22 | 439 | 0 |
| K923026 | PIKOS 01-A AND PIKOS E01-A IMPLANTABLE PACEMAKER | Biotronik, GmbH & Co. | 1993-08-19 | 422 | 0 |
| K922742 | HPM 40 HEART PACEMAKER MONITOR | Biotronik, GmbH & Co. | 1993-03-18 | 283 | 0 |
| K914109 | PIKOS 01 & PIKOS E 01 | Biotronik, GmbH & Co. | 1992-02-26 | 166 | 0 |
| K910609 | PERMANENT IMPLANTABLE JP ENDOCARDIAL LEADS W/TIP | Biotronik, GmbH & Co. | 1991-08-28 | 197 | 0 |
| K911142 | LEAD TERMINAL PIN CAPS, VARIOUS MODELS | Biotronik, GmbH & Co. | 1991-08-09 | 148 | 0 |
| K910608 | PERMANENT IMPLANTABLE FH ENDOCARDIAL LEADS W/TIP | Biotronik, GmbH & Co. | 1991-07-30 | 168 | 0 |
| K905087 | TRIOS 02 | Biotronik, GmbH & Co. | 1991-05-07 | 175 | 0 |
| K903927 | LABEL CHANGE UNIPOLAR ENDOCARDIAL LEAD, DJP 45-UP | Biotronik, GmbH & Co. | 1990-10-16 | 57 | 0 |
| K903928 | LABEL CHANGE UNIPOLAR ENDOCARDIAL LEAD DJP 53-UP | Biotronik, GmbH & Co. | 1990-10-16 | 57 | 0 |
| K903929 | LABEL CHANGE UNIPOLAR ENDOCARDIAL LEAD, DJP 60-UP | Biotronik, GmbH & Co. | 1990-10-16 | 57 | 0 |
| K903081 | NEOS (TM) 02 B PULSE GENERATOR | Biotronik, GmbH & Co. | 1990-09-14 | 64 | 0 |
| K902889 | A1-A,A1-B,A1-ABP,A1-MBP,A1-Z,A6-A,A6-B,PEH PACE. | Biotronik, GmbH & Co. | 1990-08-23 | 52 | 0 |
| K896824 | BIOTRONIK'S PS-ENDOCARDIAL LEADS | Biotronik, GmbH & Co. | 1990-08-08 | 247 | 0 |
| K901709 | DNP 60-B UNIPOLAR ENDOCARDIAL LEAD | Biotronik, GmbH & Co. | 1990-05-22 | 39 | 0 |
| K901332 | PK-55 ANDOVER MEDICAL PART #5455 LABEL CHANGE | Biotronik, GmbH & Co. | 1990-05-09 | 48 | 0 |
| K894494 | LABELING CHANGES TO PULSE GENE. & PULSE GENE. LEAD | Biotronik, GmbH & Co. | 1989-10-17 | 90 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda