Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medefil, Inc. · Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
147 daysmedian FDA review time
240 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K121262 | MEDEFLUSH NORMAL SALINE I.V. FLUSH SYRINGE-STERILE FIELD REA | Medefil, Inc. | 2012-09-20 | 147 | 0 |
| K092491 | MEDEFIL'S HEPARIN I.V. FLUSH SYRINGE 1 UNIT/ML; 10 UNITS/ML; | Medefil, Inc. | 2010-02-03 | 174 | 4 |
| K091583 | MEDEFIL'S NORMAL SALINE I.V. FLUSH SYRINGE | Medefil, Inc. | 2010-01-28 | 240 | 1 |
| K020996 | MEDEFIL'S HEPARIN I.V. FLUSH SYRINGE IN VARIOUS FILL SIZES - | Medefil, Inc. | 2002-06-24 | 88 | 0 |
| K020999 | MEDEFIL'S NORMAL SALINE FLUSH SYRINGE IN VARIOUS FILL SIZES | Medefil, Inc. | 2002-06-20 | 84 | 0 |
| K993518 | MEDEFIL'S HEPARIN I.V. FLUSH SYRINGE, IN VARIOUS FILL SIZES | Medefil, Inc. | 2000-06-12 | 238 | 0 |
| K993515 | MEDEFIL'S NORMAL SALINE FLUSH SYRINGE, IN VARIOUS FILL SIZES | Medefil, Inc. | 2000-02-25 | 130 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda