Egnell, Inc.: FDA clearances and approvals
Egnell, Inc. has 10 FDA 510(k) clearances (first 1981, latest 1985), across 6 product codes in 3 review panels. Median 510(k) review time: 74 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 |
|---|---|---|---|
| BTA | Pump, Portable, Aspiration (Manual Or Powered) | 5 | 5 |
| FMT | Warmer, Infant Radiant | 1 | 1 |
| FMZ | Incubator, Neonatal | 1 | 1 |
| FRN | Pump, Infusion | 1 | 1 |
| HGX | Pump, Breast, Powered | 1 | 1 |
| LBI | Unit, Neonatal Phototherapy | 1 | 1 |
Review panels
Most recent Egnell, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K853917 | EGNELL COMPACT SUCTION PUMP | BTA | 1985-11-25 | 63 |
| K853909 | EGNELL UNIVERSAL SUCTION PUMP | BTA | 1985-11-25 | 66 |
| K844307 | EGNELL-LACT B BATTERY-OPERATED BREAST PUMP | HGX | 1985-02-04 | 98 |
| K840526 | AMETHERM | FMZ | 1984-04-30 | 83 |
| K834335 | AMEDA PHOTOTHERAPY LAMP FOR NEWBORN | LBI | 1984-04-20 | 130 |
| K832637 | AMEDA NEONATAL RESUSCITATION UNIT- | FMT | 1983-12-22 | 140 |
| K813312 | UNIVERSAL SUCTION PUMP TYPE EUS | BTA | 1981-12-31 | 37 |
| K813095 | GASTRIC JUICES SUCTION PUMP | BTA | 1981-12-09 | 36 |
| K812898 | PE-01 ELECTRONIC INFUSION PUMP | FRN | 1981-12-02 | 47 |
| K812020 | EGNELL COMPACT, TYPE EHV | BTA | 1981-10-20 | 92 |
Recalls
openFDA lists no recalls under a recalling firm named Egnell, Inc..
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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of Egnell, Inc.'s product codes (a text match, not an official crosswalk):
- A4220 — Refill kit for implantable infusion pump (via FRN)
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via FRN)
- E0785 — Implantable intraspinal (epidural/intrathecal) catheter used with implantable infusion pump, replacement (via FRN)
Frequently asked questions
How many FDA 510(k) clearances does Egnell, Inc. have?
Egnell, Inc. has 10 FDA 510(k) clearances (first 1981, latest 1985), across 6 product codes in 3 review panels.
How long does FDA take to clear Egnell, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Egnell, Inc.'s cleared 510(k)s is 74 days.
What devices does Egnell, Inc. make?
Its most frequent FDA product codes are BTA (Pump, Portable, Aspiration (Manual Or Powered), 5); FMT (Warmer, Infant Radiant, 1); FMZ (Incubator, Neonatal, 1).
Has Egnell, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Egnell, Inc. Related entities may recall under other names.
Next steps
- See all 10 Egnell, Inc. clearances with predicates and recalls
- Run predicate analysis for product code BTA, Egnell, Inc.'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.