Syncro Medical Innovations, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Syncro Medical Innovations, Inc.” (first 2002, latest 2020), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 134 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 | 1 | 140 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 1 | 135 |
| 2020 | 1 | 133 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Syncro Medical Innovations, Inc. took a median 134 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 150 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KNT | Tubes, Gastrointestinal (And Accessories) | 4 | 4 |
| PIF | Gastrointestinal Tubes With Enteral Specific Connectors | 2 | 2 |
Review panels
Most recent Syncro Medical Innovations, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K201741 | Gabriel 3 Way EnFit Valve | PIF | 2020-11-05 | 133 |
| K191784 | Gabriel Feeding Tube with Balloon, and EnFit Connector | PIF | 2019-11-15 | 135 |
| K160787 | Gabriel Feeding Tube with Balloon, Magnetically Guided Feeding Tube w/Balloon, Gabriel Feeding Tube with Balloon, Preassembled with Stylet | KNT | 2016-08-09 | 140 |
| K110005 | SYNCRO - BLUE TUBE, THE MAGNETICALLY GUIDED ENTERAL FEEDING TUBE- 8FR TUBE | KNT | 2011-08-04 | 213 |
| K072787 | GABRIEL BLUE TUBE MAGNETICALLY GUIDED ENTERAL FEEDING TUBE, MODEL GFT-111 | KNT | 2007-10-31 | 30 |
| K021991 | MAGNAFLOW MAGNETICALLY GUIDED ENTERAL FEEDING TUBE | KNT | 2002-07-18 | 30 |
Recalls
openFDA lists no recalls under a recalling firm named Syncro Medical Innovations, 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 Syncro Medical Innovations, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Syncro Medical Innovations, Inc.” (first 2002, latest 2020), across 2 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 Syncro Medical Innovations, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Syncro Medical Innovations, Inc. is 134 days.
Which FDA product codes appear under Syncro Medical Innovations, Inc.?
The most frequent FDA product codes under this applicant name are KNT (Tubes, Gastrointestinal (And Accessories), 4); PIF (Gastrointestinal Tubes With Enteral Specific Connectors, 2).
Next steps
- See all 6 Syncro Medical Innovations, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KNT, Syncro Medical Innovations, 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.