Tpl-Cordis, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Tpl-Cordis, Inc.” (first 1987, latest 1989), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 57 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
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 |
|---|---|---|---|
| DXY | Implantable Pacemaker Pulse-Generator | 4 | 4 |
| DTB | Permanent Pacemaker Electrode | 1 | 1 |
| KRG | Programmer, Pacemaker | 1 | 1 |
Review panels
- Cardiovascular (6)
Most recent Tpl-Cordis, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K885240 | MODIFIED ANCOR & HI-FLEX UNIPOLAR ACTIVE FIX. LEAD | DTB | 1989-02-10 | 51 |
| K882429 | MODEL 255A PROGRAMMER III, W/SOFTWARE REVI. 4004 | KRG | 1988-07-22 | 38 |
| K880898 | MULTICOR AND PACEMAKERS | DXY | 1988-05-06 | 70 |
| K880432 | VICOR PACER, MODEL 410A | DXY | 1988-02-22 | 25 |
| K873158 | MODIFIED MULTICOR AND OMNI-STANICOR PACEMAKERS | DXY | 1988-01-07 | 150 |
| K873202 | VICOR, MODEL 410A | DXY | 1987-10-15 | 63 |
Recalls
openFDA lists no recalls under a recalling firm named Tpl-Cordis, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Tpl-Cordis, Inc. (a text match, not an official crosswalk):
- C1767 — Generator, neurostimulator (implantable), non-rechargeable (via DXY)
- C1820 — Generator, neurostimulator (implantable), with rechargeable battery and charging system (via DXY)
Frequently asked questions
How many FDA 510(k) clearances are listed under Tpl-Cordis, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Tpl-Cordis, Inc.” (first 1987, latest 1989), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Tpl-Cordis, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Tpl-Cordis, Inc. is 57 days.
Which FDA product codes appear under Tpl-Cordis, Inc.?
The most frequent FDA product codes under this applicant name are DXY (Implantable Pacemaker Pulse-Generator, 4); DTB (Permanent Pacemaker Electrode, 1); KRG (Programmer, Pacemaker, 1).
Next steps
- See all 6 Tpl-Cordis, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DXY, Tpl-Cordis, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.