Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Epic Medical Equipment Services, Inc. · Predicate Candidate Screening
13 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
151 daysmedian FDA review time
373 days90th percentile
13clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K012333 | FLEXI-SITE SP02 EAR SENSOR | Epic Medical Equipment Services, Inc. | 2001-10-17 | 85 | 0 |
| K002848 | SPO2 WRAP SENSOR | Epic Medical Equipment Services, Inc. | 2001-05-24 | 253 | 0 |
| K010718 | FLEXI-SITE SP02 EAR SENSOR | Epic Medical Equipment Services, Inc. | 2001-03-23 | 11 | 0 |
| K002223 | EPIC SPO2 FINGER SENSOR, MODEL E412-20 | Epic Medical Equipment Services, Inc. | 2000-08-22 | 29 | 0 |
| K000831 | STAT-SHELL DISPOSABLE SP02 SENSOR | Epic Medical Equipment Services, Inc. | 2000-06-05 | 83 | 0 |
| K992811 | TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITOR | Epic Medical Equipment Services, Inc. | 2000-01-18 | 151 | 0 |
| K992092 | STAT-SHELL DISPOSABLE SPO2 SENSOR | Epic Medical Equipment Services, Inc. | 1999-12-22 | 184 | 0 |
| K992211 | SPO2 WRAP SENSOR | Epic Medical Equipment Services, Inc. | 1999-12-22 | 174 | 0 |
| K990082 | EPIC SPO2 FINGER SENSOR, MODEL E403-09, E412-09 AND EPIC OXI | Epic Medical Equipment Services, Inc. | 1999-04-09 | 88 | 0 |
| K970098 | E100 SERIES SPO2 SENSORS | Epic Medical Equipment Services, Inc. | 1998-04-30 | 472 | 1 |
| K965172 | OXIMETER PRE-AMP CABLE | Epic Medical Equipment Services, Inc. | 1997-07-16 | 204 | 0 |
| K964055 | FLEXI-SITE (E203-01)/ FLEXI-FIT (E300) | Epic Medical Equipment Services, Inc. | 1997-02-21 | 135 | 0 |
| K954168 | E100A PULSE OXIMETER FINGER SENSOR/PROBE | Epic Medical Equipment Services, Inc. | 1996-09-12 | 373 | 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