Cardiac Pacemakers, Inc.: FDA clearances and approvals
Cardiac Pacemakers, Inc. has 76 FDA 510(k) clearances (first 1977, latest 2010), across 18 product codes in 4 review panels. Median 510(k) review time: 44 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 |
|---|---|---|---|
| DXY | Implantable Pacemaker Pulse-Generator | 37 | 37 |
| FRN | Pump, Infusion | 8 | 8 |
| KRG | Programmer, Pacemaker | 7 | 7 |
| DTD | Pacemaker Lead Adaptor | 5 | 5 |
| DQY | Catheter, Percutaneous | 2 | 2 |
| DRB | Stylet, Catheter | 2 | 2 |
| DWS | Instruments, Surgical, Cardiovascular | 2 | 2 |
| DXH | Transmitters And Receivers, Electrocardiograph, Telephone | 2 | 2 |
| DRF | Catheter, Electrode Recording, Or Probe, Electrode Recording | 1 | 1 |
| DRR | Amplifier And Signal Conditioner, Biopotential | 1 | 1 |
Plus 8 more product codes.
Review panels
Most recent Cardiac Pacemakers, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K093969 | ACUITY BREAK-AWAY GUIDE CATHETER | DQY | 2010-03-05 | 72 |
| K080154 | ACUITY UNIVERSAL CUTTER | DQY | 2008-03-20 | 57 |
| K934727 | REPLACEMENT PARTS FOR CPI 6888 LEAD TUNNELER | DWS | 1994-01-10 | 101 |
| K920601 | ASTRA T2, ASTRA T4, ASTRA T6 | DXY | 1992-10-28 | 260 |
| K912379 | PDT CARRYALL TRANSMITTER, VARIOUS MODELS | DXH | 1991-06-17 | 19 |
| K905674 | LEAD STYLET | DRB | 1991-01-30 | 43 |
| K900498 | MODIFIED BETATRON IV INSULIN INFUSION SYSTEM | LZG | 1990-02-23 | 36 |
| K894738 | MODEL 6888 LEAD TUNNELER | DWS | 1989-09-13 | 48 |
| K890785 | ASTRA T2, T3, T4, T6 PULSE GENERATORS NEW PACKAGE | DXY | 1989-03-10 | 23 |
| K875147 | TORQUE HEX WRENCH | DTF | 1988-01-27 | 43 |
66 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Cardiac Pacemakers, 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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of Cardiac Pacemakers, Inc.'s product codes (a text match, not an official crosswalk):
- A4220 — Refill kit for implantable infusion pump (via FRN)
- C1767 — Generator, neurostimulator (implantable), non-rechargeable (via DXY)
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via FRN)
- C1820 — Generator, neurostimulator (implantable), with rechargeable battery and charging system (via DXY)
- E0785 — Implantable intraspinal (epidural/intrathecal) catheter used with implantable infusion pump, replacement (via FRN)
Frequently asked questions
How many FDA 510(k) clearances does Cardiac Pacemakers, Inc. have?
Cardiac Pacemakers, Inc. has 76 FDA 510(k) clearances (first 1977, latest 2010), across 18 product codes in 4 review panels.
How long does FDA take to clear Cardiac Pacemakers, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Cardiac Pacemakers, Inc.'s cleared 510(k)s is 44 days.
What devices does Cardiac Pacemakers, Inc. make?
Its most frequent FDA product codes are DXY (Implantable Pacemaker Pulse-Generator, 37); FRN (Pump, Infusion, 8); KRG (Programmer, Pacemaker, 7).
Has Cardiac Pacemakers, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Cardiac Pacemakers, Inc. Related entities may recall under other names.
Next steps
- See all 76 Cardiac Pacemakers, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DXY, Cardiac Pacemakers, 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.