Epcom Medical Systems, Inc.: FDA filings under this applicant name
FDA lists 13 510(k) clearances under the applicant name “Epcom Medical Systems, Inc.” (first 1981, latest 1991), across 10 product codes in 3 review panels. Median 510(k) review time under this name: 92 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 |
|---|---|---|---|
| HGM | System, Monitoring, Perinatal | 4 | 4 |
| FAP | Cystometric Gas (Carbon-Dioxide) On Hydraulic Device | 1 | 1 |
| FFG | Device, Urine Flow Rate Measuring, Non-Electrical, Disposable | 1 | 1 |
| HDR | Cap, Cervical | 1 | 1 |
| HGE | Amniotome | 1 | 1 |
| HGP | Electrode, Circular (Spiral), Scalp And Applicator | 1 | 1 |
| HGS | Catheter, Intrauterine And Introducer | 1 | 1 |
| HHI | System, Abortion, Vacuum | 1 | 1 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 1 | 1 |
| KNG | Monitor, Ultrasonic, Fetal | 1 | 1 |
Review panels
Most recent Epcom Medical Systems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K910518 | GLOVE-N-GEL AMNIOTOMY KIT | HGE | 1991-05-09 | 92 |
| K905812 | INTRAUTERINE CATHETER SET | HGS | 1991-01-31 | 34 |
| K881414 | CERVICATH | HDR | 1988-06-14 | 71 |
| K871079 | FETALFLEX FETAL ELECTRODE | HGP | 1987-07-13 | 117 |
| K844338 | 1URO-LOG HOME DIAGNOSTIC PACK | FFG | 1985-02-25 | 109 |
| K844503 | UROSTRESSTIK DIAGNOSTIC CYSTOMETRY PACK | FAP | 1985-01-02 | 43 |
| K841805 | OBSTETRICAL DOPPLER | KNG | 1984-06-19 | 49 |
| K831115 | EPCOM EMS-320 REMOTE MONITORSCOPE | HGM | 1983-08-12 | 129 |
| K831114 | EPCOM EMS-330 FREEDOM I TELEDOP OBSTET | HGM | 1983-08-12 | 129 |
| K831113 | EPCOM EMS-310 INTRAPARTUM MONITOR | HGM | 1983-08-12 | 129 |
3 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Epcom Medical Systems, 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Epcom Medical Systems, Inc.?
FDA lists 13 510(k) clearances under the applicant name “Epcom Medical Systems, Inc.” (first 1981, latest 1991), across 10 product codes in 3 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 Epcom Medical Systems, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Epcom Medical Systems, Inc. is 92 days.
Which FDA product codes appear under Epcom Medical Systems, Inc.?
The most frequent FDA product codes under this applicant name are HGM (System, Monitoring, Perinatal, 4); FAP (Cystometric Gas (Carbon-Dioxide) On Hydraulic Device, 1); FFG (Device, Urine Flow Rate Measuring, Non-Electrical, Disposable, 1).
Next steps
- See all 13 Epcom Medical Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HGM, Epcom Medical Systems, 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.