American Pacemaker Corp.: FDA filings under this applicant name
FDA lists 14 510(k) clearances under the applicant name “American Pacemaker Corp.” (first 1977, latest 1982), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 86 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 | 7 | 7 |
| DTB | Permanent Pacemaker Electrode | 6 | 6 |
| DTE | Pulse-Generator, Pacemaker, External | 1 | 1 |
Review panels
- Cardiovascular (14)
Most recent American Pacemaker Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K821791 | EXTERNAL PULSE GENERATOR - EV4542 | DTE | 1982-07-06 | 19 |
| K812830 | APC IMPLANTABLE PACING LEAD | DTB | 1982-01-18 | 102 |
| K812807 | APC IMPLANTABLE PACING LEADS | DTB | 1982-01-18 | 104 |
| K810399 | APC IMPLANTABEL PACING LEAD, MODEL 3264 | DTB | 1981-05-15 | 86 |
| K810398 | APC IMPLANTABLE PACING LEAD, MODEL 3266 | DTB | 1981-05-15 | 86 |
| K810397 | APC IMPLANTABLE PACING LEAD-FLANGE #3260 | DTB | 1981-05-15 | 86 |
| K810396 | APC IMPLANTABLE PACING LEAD, TINED #3262 | DTB | 1981-05-15 | 86 |
| K810121 | UNIFOCAL 3 | DXY | 1981-02-23 | 35 |
| K800746 | UNIFOCAL VP, MODELS 7501 AND 7502 | DXY | 1980-12-16 | 257 |
| K800379 | BIFOCAL 2 8200 SERIES (A,B C,D) | DXY | 1980-09-26 | 217 |
4 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named American Pacemaker Corp..
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 American Pacemaker Corp. (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)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- American Dade (149 510(k)s)
- American Edwards Laboratories (89 510(k)s)
- American Medical Systems, Inc. (82 510(k)s)
- American Bioproducts Co. (79 510(k)s)
- American Monitor Corp. (73 510(k)s)
- American Pharmaseal Div. Ahsc (64 510(k)s)
- American Bentley (59 510(k)s)
- American Hospital Supply Corp. (56 510(k)s)
- American Research Products Co. (56 510(k)s)
- American Orthodontics (46 510(k)s)
- American Diagnostic Corp. (39 510(k)s)
- American Laboratory Supply, Inc. (36 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under American Pacemaker Corp.?
FDA lists 14 510(k) clearances under the applicant name “American Pacemaker Corp.” (first 1977, latest 1982), 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 American Pacemaker Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name American Pacemaker Corp. is 86 days.
Which FDA product codes appear under American Pacemaker Corp.?
The most frequent FDA product codes under this applicant name are DXY (Implantable Pacemaker Pulse-Generator, 7); DTB (Permanent Pacemaker Electrode, 6); DTE (Pulse-Generator, Pacemaker, External, 1).
Next steps
- See all 14 American Pacemaker Corp. clearances with predicates and recalls
- Run predicate analysis for product code DXY, American Pacemaker Corp.'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.