Arco Medical Products Co.: FDA clearances and approvals
Arco Medical Products Co. has 21 FDA 510(k) clearances (first 1976, latest 1980), across 6 product codes in 2 review panels. Median 510(k) review time: 30 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 | 15 | 15 |
| DTD | Pacemaker Lead Adaptor | 2 | 2 |
| DPS | Electrocardiograph | 1 | 1 |
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | 1 | 1 |
| DTB | Permanent Pacemaker Electrode | 1 | 1 |
| IKY | Mattress, Flotation Therapy, Non-Powered | 1 | 1 |
Review panels
- Cardiovascular (20)
- General Hospital (1)
Most recent Arco Medical Products Co. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K802588 | MODEL 3003 UNIPOLAR DEMAND CARDIAC GEN. | DXY | 1980-11-19 | 30 |
| K801806 | EXTERNAL SILASTIC BOOT FOR CARDIAC PULSE | DXY | 1980-09-09 | 41 |
| K801241 | UNIPOLAR PROGRAMMABLE LITHIUM CARD. GEN. | DXY | 1980-06-30 | 34 |
| K800837 | PROGRAMMABLE BIPOLAR CARDIAC GENERATOR | DXY | 1980-06-30 | 76 |
| K800838 | ARCOLITH 3022&ARCOLITH 3023 CARDIAC GEN. | DXY | 1980-06-04 | 50 |
| K800326 | ARCOLITH 3021-CARDIAC PULSE GENERATOR | DXY | 1980-03-17 | 34 |
| K792299 | ARCOLITH 3020-CARDIAC PULSE GENERATOR | DXY | 1979-11-29 | 15 |
| K792216 | ARCOLITH 2100-CARDIAC PULSE GENERATOR | DXY | 1979-11-29 | 24 |
| K791715 | ARCOLITH 2000 | DXY | 1979-09-27 | 27 |
| K791147 | ARCO PROGAMMABLE PACEMAKER SYSTEM | DXY | 1979-08-03 | 46 |
11 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Arco Medical Products Co..
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 Arco Medical Products Co.'s product codes (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 does Arco Medical Products Co. have?
Arco Medical Products Co. has 21 FDA 510(k) clearances (first 1976, latest 1980), across 6 product codes in 2 review panels.
How long does FDA take to clear Arco Medical Products Co.'s 510(k)s?
The median time from FDA receipt to decision across Arco Medical Products Co.'s cleared 510(k)s is 30 days.
What devices does Arco Medical Products Co. make?
Its most frequent FDA product codes are DXY (Implantable Pacemaker Pulse-Generator, 15); DTD (Pacemaker Lead Adaptor, 2); DPS (Electrocardiograph, 1).
Has Arco Medical Products Co. had device recalls?
openFDA lists no recalls under a recalling firm name matching Arco Medical Products Co. Related entities may recall under other names.
Next steps
- See all 21 Arco Medical Products Co. clearances with predicates and recalls
- Run predicate analysis for product code DXY, Arco Medical Products Co.'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.