Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
Edentec Corp. — Predicate Candidate Screening
18 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
108 daysmedian FDA review time
316 days90th percentile
18clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K953363 | OXIFLOW DIGITAL RECORDER | Edentec Corp. | 1996-02-06 | 204 | 0 |
| K953540 | EEE | Edentec Corp. | 1995-08-25 | 28 | 0 |
| K921819 | EDENTEC MODEL 3710 I DIGITAL PRINTER | Edentec Corp. | 1993-10-22 | 555 | 0 |
| K913749 | EDENTRACE AIRFLOW 3171/SLEEP LAB AIRFLOW 3170 | Edentec Corp. | 1992-07-02 | 316 | 0 |
| K910870 | EDENTEC MODEL 3711 DIGITAL RECORDER | Edentec Corp. | 1991-08-29 | 181 | 0 |
| K910871 | EDENTEC DIGITAL CHARTER MODEL 3710 | Edentec Corp. | 1991-08-29 | 181 | 0 |
| K905575 | MODIFIED MODELS 2000W AND 2000W OPTION H APNEA MON | Edentec Corp. | 1991-06-20 | 190 | 0 |
| K901060 | EDENTEC MODEL 2000W SYSTEM 700 MONITOR | Edentec Corp. | 1990-05-15 | 70 | 0 |
| K893561 | EDENTRACE 670 SYSTEM MULTICHANNEL RECORDER W/OXIM. | Edentec Corp. | 1989-08-25 | 108 | 0 |
| K892227 | EDENTEC MODEL 2001 MODULAR MEMORY UNIT (MMU) | Edentec Corp. | 1989-06-20 | 77 | 0 |
| K891540 | EDENTEC MODEL 2860 PRESSURE METER | Edentec Corp. | 1989-06-01 | 76 | 0 |
| K884614 | EDENTEC MODEL 2000W OPTION S CARDIO-RESP. PROCESS. | Edentec Corp. | 1989-02-01 | 89 | 0 |
| K884388 | EDENTEC MODEL 4700 SCANNER | Edentec Corp. | 1989-01-10 | 84 | 0 |
| K883315 | EDENTRACE MULTI-CHARTER MODEL 3700 | Edentec Corp. | 1988-12-28 | 145 | 0 |
| K881820 | EDENTEC MODEL 2800/2801 OXIMETER/PULSE OXIMETER | Edentec Corp. | 1988-07-18 | 80 | 0 |
| K873081 | EDENTEC MULTI-CHANNEL RECORDER | Edentec Corp. | 1987-11-17 | 104 | 0 |
| K871302 | MODEL 2000W OPTION H CONFIGURATION | Edentec Corp. | 1987-04-20 | 19 | 0 |
| K844327 | EDENTEC MODEL 2000W APNEA MONITOR | Edentec Corp. | 1985-07-15 | 250 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda