Pacesetter, Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Pacesetter, Inc.” (first 1995, latest 1998), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 118 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Abbott, based on public ownership records.
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 |
| CAF | Nebulizer (Direct Patient Interface) | 1 | 1 |
| DTD | Pacemaker Lead Adaptor | 1 | 1 |
Review panels
- Cardiovascular (7)
- Anesthesiology (1)
Most recent Pacesetter, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K972814 | LOCATOR MODEL 4036 | DTB | 1998-02-23 | 209 |
| K960854 | SIEMENS SERVO ULTRA NEBULIZER 345 | CAF | 1996-12-23 | 297 |
| K954714 | AFP CARDIAC PACING SYSTEM MODEL 283 (MODIFICATION) | DTB | 1996-02-01 | 122 |
| K954551 | DF-1 TERMINAL CAP | DTB | 1995-12-26 | 85 |
| K952206 | PASSIVE PLUS PACING LEADS WITH TITANIUM NITRIDE COATING | DTB | 1995-08-31 | 113 |
| K951950 | PASSIVE PLUS PACING LEADS WITH TITANIUM NITRIDE COATING | DTB | 1995-08-31 | 127 |
| K951087 | TENDRIL, UNIPOLAR ENDOCARDIAL SCREW-IN LEAD | DTB | 1995-06-29 | 112 |
| K950140 | IS-1/QUADRIPOLAR TERMINAL CAP, PART NUMBER 6011069 | DTD | 1995-04-06 | 83 |
Recalls
openFDA lists no recalls under a recalling firm named Pacesetter, 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 Pacesetter, Inc. (a text match, not an official crosswalk):
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.
- Pacesetter Systems (96 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Pacesetter, Inc.?
FDA lists 8 510(k) clearances under the applicant name “Pacesetter, Inc.” (first 1995, latest 1998), across 3 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Pacesetter, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Pacesetter, Inc. is 118 days.
Which FDA product codes appear under Pacesetter, Inc.?
The most frequent FDA product codes under this applicant name are DTB (Permanent Pacemaker Electrode, 6); CAF (Nebulizer (Direct Patient Interface), 1); DTD (Pacemaker Lead Adaptor, 1).
Next steps
- See all 8 Pacesetter, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DTB, Pacesetter, 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.