Epic Medical Equipment Services, Inc.: FDA filings under this applicant name
FDA lists 13 510(k) clearances under the applicant name “Epic Medical Equipment Services, Inc.” (first 1996, latest 2001), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 151 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
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 |
|---|---|---|---|
| DQA | Oximeter | 10 | 10 |
| DPZ | Oximeter, Ear | 2 | 2 |
| HFM | Monitor, Uterine Contraction, External (For Use In Clinic) | 1 | 1 |
Review panels
Most recent Epic Medical Equipment Services, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K012333 | FLEXI-SITE SP02 EAR SENSOR | DPZ | 2001-10-17 | 85 |
| K002848 | SPO2 WRAP SENSOR | DQA | 2001-05-24 | 253 |
| K010718 | FLEXI-SITE SP02 EAR SENSOR | DPZ | 2001-03-23 | 11 |
| K002223 | EPIC SPO2 FINGER SENSOR, MODEL E412-20 | DQA | 2000-08-22 | 29 |
| K000831 | STAT-SHELL DISPOSABLE SP02 SENSOR | DQA | 2000-06-05 | 83 |
| K992811 | TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORING | HFM | 2000-01-18 | 151 |
| K992211 | SPO2 WRAP SENSOR | DQA | 1999-12-22 | 174 |
| K992092 | STAT-SHELL DISPOSABLE SPO2 SENSOR | DQA | 1999-12-22 | 184 |
| K990082 | EPIC SPO2 FINGER SENSOR, MODEL E403-09, E412-09 AND EPIC OXIMETER CABLE, MODEL E710-09 | DQA | 1999-04-09 | 88 |
| K970098 | E100 SERIES SPO2 SENSORS | DQA | 1998-04-30 | 472 |
3 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Epic Medical Equipment Services, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Epic Medical Pte. , Ltd. (22 510(k)s)
- Epic Extremity, LLC (5 510(k)s)
- Epic Systems, Inc. (4 510(k)s)
- Epic Extremely, LLC (1 510(k)s)
- Epic Medical Concepts & Innovations (1 510(k)s)
- Epic Research & Diagnostics, Inc. (0 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Epic Medical Equipment Services, Inc.?
FDA lists 13 510(k) clearances under the applicant name “Epic Medical Equipment Services, Inc.” (first 1996, latest 2001), across 3 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Epic Medical Equipment Services, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Epic Medical Equipment Services, Inc. is 151 days.
Which FDA product codes appear under Epic Medical Equipment Services, Inc.?
The most frequent FDA product codes under this applicant name are DQA (Oximeter, 10); DPZ (Oximeter, Ear, 2); HFM (Monitor, Uterine Contraction, External (For Use In Clinic), 1).
Next steps
- See all 13 Epic Medical Equipment Services, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DQA, Epic Medical Equipment Services, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.