Edentec Corp.: FDA clearances and approvals
Edentec Corp. has 18 FDA 510(k) clearances (first 1985, latest 1996), across 7 product codes in 2 review panels. Median 510(k) review time: 106 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 |
|---|---|---|---|
| BZQ | Monitor, Breathing Frequency | 6 | 6 |
| DQA | Oximeter | 4 | 4 |
| DSF | Recorder, Paper Chart | 4 | 4 |
| BYD | Condenser, Heat And Moisture (Artificial Nose) | 1 | 1 |
| BYE | Attachment, Breathing, Positive End Expiratory Pressure | 1 | 1 |
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | 1 | 1 |
| DSH | Recorder, Magnetic Tape, Medical | 1 | 1 |
Review panels
- Anesthesiology (12)
- Cardiovascular (6)
Most recent Edentec Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K953363 | OXIFLOW DIGITAL RECORDER | BZQ | 1996-02-06 | 204 |
| K953540 | EEE | BYD | 1995-08-25 | 28 |
| K921819 | EDENTEC MODEL 3710 I DIGITAL PRINTER | BZQ | 1993-10-22 | 555 |
| K913749 | EDENTRACE AIRFLOW 3171/SLEEP LAB AIRFLOW 3170 | BZQ | 1992-07-02 | 316 |
| K910871 | EDENTEC DIGITAL CHARTER MODEL 3710 | DSF | 1991-08-29 | 181 |
| K910870 | EDENTEC MODEL 3711 DIGITAL RECORDER | DRT | 1991-08-29 | 181 |
| K905575 | MODIFIED MODELS 2000W AND 2000W OPTION H APNEA MON | BZQ | 1991-06-20 | 190 |
| K901060 | EDENTEC MODEL 2000W SYSTEM 700 MONITOR | DQA | 1990-05-15 | 70 |
| K893561 | EDENTRACE 670 SYSTEM MULTICHANNEL RECORDER W/OXIM. | DSF | 1989-08-25 | 108 |
| K892227 | EDENTEC MODEL 2001 MODULAR MEMORY UNIT (MMU) | DSH | 1989-06-20 | 77 |
8 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Edentec Corp..
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 Edentec Corp. have?
Edentec Corp. has 18 FDA 510(k) clearances (first 1985, latest 1996), across 7 product codes in 2 review panels.
How long does FDA take to clear Edentec Corp.'s 510(k)s?
The median time from FDA receipt to decision across Edentec Corp.'s cleared 510(k)s is 106 days.
What devices does Edentec Corp. make?
Its most frequent FDA product codes are BZQ (Monitor, Breathing Frequency, 6); DQA (Oximeter, 4); DSF (Recorder, Paper Chart, 4).
Has Edentec Corp. had device recalls?
openFDA lists no recalls under a recalling firm name matching Edentec Corp. Related entities may recall under other names.
Next steps
- See all 18 Edentec Corp. clearances with predicates and recalls
- Run predicate analysis for product code BZQ, Edentec Corp.'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.