Entracare, LLC: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Entracare, LLC” (first 1994, latest 2009), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 72 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 |
|---|---|---|---|
| KNT | Tubes, Gastrointestinal (And Accessories) | 3 | 3 |
| EZL | Catheter, Retention Type, Balloon | 1 | 1 |
| FLL | Continuous Measurement Thermometer | 1 | 1 |
| LZH | Pump, Infusion, Enteral | 1 | 1 |
Review panels
Most recent Entracare, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K092418 | ENTRACARE GASTROSTOMY FEEDING TUBE | KNT | 2009-10-23 | 78 |
| K053429 | ADVANCED UROLOGICAL CATHETER | EZL | 2006-02-08 | 61 |
| K041034 | SKIN LEVEL GASTROSTOMY TUBE KIT (ECSL) | KNT | 2004-08-31 | 132 |
| K964851 | ENTRACARE THERMOMTER MODEL 1000 | FLL | 1997-02-03 | 62 |
| K952671 | RATESAVER PLUS | LZH | 1995-08-18 | 67 |
| K925261 | NUTRICARE ENTERAL FEEDING TUBE | KNT | 1994-02-17 | 486 |
Recalls
openFDA lists no recalls under a recalling firm named Entracare, LLC.
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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Entracare, LLC (a text match, not an official crosswalk):
- A4220 — Refill kit for implantable infusion pump (via LZH)
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via LZH)
Frequently asked questions
How many FDA 510(k) clearances are listed under Entracare, LLC?
FDA lists 6 510(k) clearances under the applicant name “Entracare, LLC” (first 1994, latest 2009), across 4 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 Entracare, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Entracare, LLC is 72 days.
Which FDA product codes appear under Entracare, LLC?
The most frequent FDA product codes under this applicant name are KNT (Tubes, Gastrointestinal (And Accessories), 3); EZL (Catheter, Retention Type, Balloon, 1); FLL (Continuous Measurement Thermometer, 1).
Next steps
- See all 6 Entracare, LLC clearances with predicates and recalls
- Run predicate analysis for product code KNT, Entracare, LLC'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.