Cook Pacemaker Corp.: FDA filings under this applicant name
FDA lists 34 510(k) clearances under the applicant name “Cook Pacemaker Corp.” (first 1981, latest 1997), plus 1 PMA decision, across 5 product codes in 1 review panel. Median 510(k) review time under this name: 33 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 Cook Medical, 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 |
|---|---|---|---|
| DXY | Implantable Pacemaker Pulse-Generator | 25 | 24 |
| DTB | Permanent Pacemaker Electrode | 7 | 7 |
| DQX | Wire, Guide, Catheter | 1 | 1 |
| DXE | Catheter, Embolectomy | 1 | 1 |
Plus 1 more product codes.
Review panels
- Cardiovascular (34)
Most recent Cook Pacemaker Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K970690 | LOCKING STYLET 2 | DQX | 1997-05-20 | 84 |
| K961992 | NEEDLE'S EYE SNARE | DXE | 1996-12-27 | 220 |
| K953417 | MINIFLEX MODEL 340, 341, AND 342 PULSE GENERATORS | DXY | 1995-09-29 | 113 |
| K915188 | MODEL P IN-LINE BIPOLAR ENDOCARDIAL TINED LEAD | DTB | 1992-09-11 | 298 |
| K905403 | MODEL 340 SERIES UNIPOLAR & MODEL 5000B PROGRAMMER | DXY | 1991-10-16 | 317 |
| K863582 | MODEL 725TH HANDHELD TRANSCEIVER (PROGRAMMER) | DXY | 1986-10-08 | 23 |
| K861559 | SERIES (T) PROGRAMMABLE CARDIAC PULSE GENERATORS | DXY | 1986-05-09 | 14 |
| K860466 | MODEL 329D, SERIERS R BIOPOLAR CARDIAC PUL. GEN. | DXY | 1986-02-24 | 18 |
| K860202 | MODEL 327D, SERIES R UNIPOLAR CARDIAC PULSE GENER. | DXY | 1986-02-24 | 33 |
| K854919 | BIPOLAR CARDIAC PULSE GENERATOR WITH TELEMETRY | DXY | 1985-12-19 | 10 |
24 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P870054 | PMA | KELVIN MODEL 500 UNIPOLAR CARDIAC PULSE GENERATOR | 1988-04-29 |
Recalls
openFDA lists no recalls under a recalling firm named Cook 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 Cook 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.
- Cook, Inc. (364 510(k)s)
- Cook Urological, Inc. (104 510(k)s)
- Cook Biotech, Inc. (47 510(k)s)
- Cook Ob/Gyn (43 510(k)s)
- Cook Ireland, Ltd. (32 510(k)s)
- Cook Vascular, Inc. (12 510(k)s)
- Cook Endoscopy (4 510(k)s)
- Cook Biotech Incorprated (4 510(k)s)
- Cook Medical (1 510(k)s)
- Cook Advanced Technologies (1 510(k)s)
- Cook (Canada), Inc. (1 510(k)s)
- Cook Corporated (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Cook Pacemaker Corp.?
FDA lists 34 510(k) clearances under the applicant name “Cook Pacemaker Corp.” (first 1981, latest 1997), plus 1 PMA decision, across 5 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 Cook Pacemaker Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Cook Pacemaker Corp. is 33 days.
Which FDA product codes appear under Cook Pacemaker Corp.?
The most frequent FDA product codes under this applicant name are DXY (Implantable Pacemaker Pulse-Generator, 25); DTB (Permanent Pacemaker Electrode, 7); DQX (Wire, Guide, Catheter, 1).
Next steps
- See all 34 Cook Pacemaker Corp. clearances with predicates and recalls
- Run predicate analysis for product code DXY, Cook 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.