Circadian, Inc.: FDA clearances and approvals
Circadian, Inc. has 13 FDA 510(k) clearances (first 1980, latest 1992), across 6 product codes in 3 review panels. Median 510(k) review time: 105 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 |
|---|---|---|---|
| DPS | Electrocardiograph | 4 | 4 |
| DSI | Detector And Alarm, Arrhythmia | 3 | 3 |
| DSH | Recorder, Magnetic Tape, Medical | 2 | 2 |
| KRC | Tester, Electrode, Surface, Electrocardiographic | 2 | 2 |
| BZG | Spirometer, Diagnostic | 1 | 1 |
| IYP | Phantom, Anthropomorphic, Nuclear | 1 | 1 |
Review panels
- Cardiovascular (11)
- Anesthesiology (1)
- Radiology (1)
Most recent Circadian, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K921878 | SCANMATE III | IYP | 1992-09-11 | 144 |
| K894956 | CIRCAMED HOLTER VERSION 4 | DPS | 1990-02-05 | 185 |
| K874641 | CIRCADIAN STRESS TEST II | DPS | 1988-04-01 | 140 |
| K874155 | CIRCAMED MONITOR REMOTE START CONDUCTANCE METER | KRC | 1987-11-23 | 41 |
| K871251 | CIRCAMED FULL DISCLOSURE SYSTEM | DSI | 1987-05-22 | 53 |
| K860973 | CIRCADIAN STRESS TEST SYSTEM | DPS | 1986-08-25 | 164 |
| K851517 | CIRCA MED SINGLE-CHANNEL-AMBULATORY CARDIAC MONITO | DSI | 1985-10-02 | 170 |
| K851643 | REMOTE CONTROL MODULE | DPS | 1985-09-09 | 143 |
| K840741 | PULMONARY FUNCTION TESTING STS | BZG | 1984-03-05 | 33 |
| K833619 | CONDUCTANCE METER | KRC | 1984-01-27 | 105 |
3 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Circadian, 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.
Frequently asked questions
How many FDA 510(k) clearances does Circadian, Inc. have?
Circadian, Inc. has 13 FDA 510(k) clearances (first 1980, latest 1992), across 6 product codes in 3 review panels.
How long does FDA take to clear Circadian, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Circadian, Inc.'s cleared 510(k)s is 105 days.
What devices does Circadian, Inc. make?
Its most frequent FDA product codes are DPS (Electrocardiograph, 4); DSI (Detector And Alarm, Arrhythmia, 3); DSH (Recorder, Magnetic Tape, Medical, 2).
Has Circadian, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Circadian, Inc. Related entities may recall under other names.
Next steps
- See all 13 Circadian, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DPS, Circadian, 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.