Medefil, Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Medefil, Inc.” (first 2000, latest 2012), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 147 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 | 1 | 147 |
| 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 |
|---|---|---|---|
| NGT | Saline, Vascular Access Flush | 4 | 4 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 2 | 2 |
| NZW | Heparin, Vascular Access Flush | 1 | 1 |
Review panels
- General Hospital (7)
Most recent Medefil, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K121262 | MEDEFLUSH NORMAL SALINE I.V. FLUSH SYRINGE-STERILE FIELD READY | NGT | 2012-09-20 | 147 |
| K092491 | MEDEFIL'S HEPARIN I.V. FLUSH SYRINGE 1 UNIT/ML; 10 UNITS/ML; AND 100 UNITS/ML IN VARIOUS FILL SIZES | NZW | 2010-02-03 | 174 |
| K091583 | MEDEFIL'S NORMAL SALINE I.V. FLUSH SYRINGE | NGT | 2010-01-28 | 240 |
| K020996 | MEDEFIL'S HEPARIN I.V. FLUSH SYRINGE IN VARIOUS FILL SIZES - 1 ML FILL IN 6 ML SYRINGE LL; 2 ML FILL IN 6 ML SYRINGE LL | NGT | 2002-06-24 | 88 |
| K020999 | MEDEFIL'S NORMAL SALINE FLUSH SYRINGE IN VARIOUS FILL SIZES - 1 ML FILL IN 6 ML SYRINGE LL; 2 ML FILL IN 6 ML SYRINGE LL | NGT | 2002-06-20 | 84 |
| K993518 | MEDEFIL'S HEPARIN I.V. FLUSH SYRINGE, IN VARIOUS FILL SIZES - 1 ML FILL IN 3 ML SYRINGE LL; 1 ML FILL IN 6 ML SYRINGE LL | FOZ | 2000-06-12 | 238 |
| K993515 | MEDEFIL'S NORMAL SALINE FLUSH SYRINGE, IN VARIOUS FILL SIZES - 1 ML FILL IN 3 ML SYRINGE LL; 1 ML FILL IN 6 ML SYRINGE L | FOZ | 2000-02-25 | 130 |
Recalls
openFDA lists no recalls under a recalling firm named Medefil, 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 Medefil, Inc.?
FDA lists 7 510(k) clearances under the applicant name “Medefil, Inc.” (first 2000, latest 2012), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Medefil, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Medefil, Inc. is 147 days.
Which FDA product codes appear under Medefil, Inc.?
The most frequent FDA product codes under this applicant name are NGT (Saline, Vascular Access Flush, 4); FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days, 2); NZW (Heparin, Vascular Access Flush, 1).
Next steps
- See all 7 Medefil, Inc. clearances with predicates and recalls
- Run predicate analysis for product code NGT, Medefil, 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.