Coratomic, Inc.: FDA clearances and approvals
Coratomic, Inc. has 15 FDA 510(k) clearances (first 1976, latest 1986), across 3 product codes in 1 review panel. Median 510(k) review time: 52 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 | 11 | 11 |
| DTB | Permanent Pacemaker Electrode | 3 | 3 |
Plus 1 more product codes.
Review panels
- Cardiovascular (14)
Most recent Coratomic, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K863365 | MODIFICATION OF STERILITY CYCLE PARAMETERS | DXY | 1986-10-08 | 36 |
| K822791 | CORATOMIC #VX5-105 & VX5-205 PULSE GEN. | DXY | 1982-12-15 | 91 |
| K820939 | C-101-P | DXY | 1982-06-22 | 77 |
| K821033 | CORATOMIC MODEL OVALITH-920 | DXY | 1982-05-28 | 45 |
| K821014 | CORATOMIC MODEL OVALITH 920BP | DXY | 1982-05-28 | 46 |
| K810808 | CORATOMIC MODEL OVALITH-920 | DXY | 1981-05-15 | 52 |
| K802689 | L-15T ENDOCARDIAL PACING ELECTRODE | — | 1980-10-28 | 0 |
| K800194 | OVALITH P-BP BIPOLAR CARDIAC PACEMAKER | DXY | 1980-02-11 | 13 |
| K790446 | OVALITH-300 | DXY | 1979-07-30 | 158 |
| K781377 | OVALITH 10BP | DXY | 1978-12-04 | 117 |
5 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Coratomic, 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 Coratomic, Inc.'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 Coratomic, Inc. have?
Coratomic, Inc. has 15 FDA 510(k) clearances (first 1976, latest 1986), across 3 product codes in 1 review panel.
How long does FDA take to clear Coratomic, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Coratomic, Inc.'s cleared 510(k)s is 52 days.
What devices does Coratomic, Inc. make?
Its most frequent FDA product codes are DXY (Implantable Pacemaker Pulse-Generator, 11); DTB (Permanent Pacemaker Electrode, 3).
Has Coratomic, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Coratomic, Inc. Related entities may recall under other names.
Next steps
- See all 15 Coratomic, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DXY, Coratomic, 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.