Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Syncro Medical Innovations, Inc. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
135 daysmedian FDA review time
213 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K201741 | Gabriel 3 Way EnFit Valve | Syncro Medical Innovations, Inc. | 2020-11-05 | 133 | 0 |
| K191784 | Gabriel Feeding Tube with Balloon, and EnFit Connector | Syncro Medical Innovations, Inc. | 2019-11-15 | 135 | 0 |
| K160787 | Gabriel Feeding Tube with Balloon, Magnetically Guided Feedi | Syncro Medical Innovations, Inc. | 2016-08-09 | 140 | 0 |
| K110005 | SYNCRO - BLUE TUBE, THE MAGNETICALLY GUIDED ENTERAL FEEDING | Syncro Medical Innovations, Inc. | 2011-08-04 | 213 | 0 |
| K072787 | GABRIEL BLUE TUBE MAGNETICALLY GUIDED ENTERAL FEEDING TUBE, | Syncro Medical Innovations, Inc. | 2007-10-31 | 30 | 0 |
| K021991 | MAGNAFLOW MAGNETICALLY GUIDED ENTERAL FEEDING TUBE | Syncro Medical Innovations, Inc. | 2002-07-18 | 30 | 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