Siemens-Pacesetter, Inc.: FDA clearances and approvals
Siemens-Pacesetter, Inc. has 7 FDA 510(k) clearances (first 1992, latest 1994), across 2 product codes in 1 review panel. Median 510(k) review time: 333 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DTB | Permanent Pacemaker Electrode | 6 | 6 |
| DTD | Pacemaker Lead Adaptor | 1 | 1 |
Review panels
- Cardiovascular (7)
Most recent Siemens-Pacesetter, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K942440 | AFP CARDIAC PACING SYSTEM MODEL 283 | DTB | 1994-08-08 | 80 |
| K925038 | PACING LEAD MODEL 1188T | DTB | 1994-07-15 | 648 |
| K932892 | PASSIVE PLUS ENDOCARDIAL PACING LEADS VAR. MODELS | DTB | 1994-07-06 | 387 |
| K930876 | SILICONE BIPOLAR LEAD MODELS 1136T, 1142T &1146T | DTB | 1994-06-15 | 481 |
| K925347 | MODEL 1148T TRANSVENOUS, SCREW-IN LEAD | DTB | 1993-06-10 | 231 |
| K920822 | CARDIOVASCULAR PERMANENT PACEMAKER ELECTRODE | DTB | 1993-01-22 | 333 |
| K921318 | ADAPTING SLEEVE KIT MODEL 4023 | DTD | 1992-08-03 | 137 |
Recalls
openFDA lists no recalls under a recalling firm named Siemens-Pacesetter, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Siemens-Pacesetter, Inc. have?
Siemens-Pacesetter, Inc. has 7 FDA 510(k) clearances (first 1992, latest 1994), across 2 product codes in 1 review panel.
How long does FDA take to clear Siemens-Pacesetter, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Siemens-Pacesetter, Inc.'s cleared 510(k)s is 333 days.
What devices does Siemens-Pacesetter, Inc. make?
Its most frequent FDA product codes are DTB (Permanent Pacemaker Electrode, 6); DTD (Pacemaker Lead Adaptor, 1).
Has Siemens-Pacesetter, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Siemens-Pacesetter, Inc. Related entities may recall under other names.
Next steps
- See all 7 Siemens-Pacesetter, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DTB, Siemens-Pacesetter, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.