Kentec Medical, Inc
FDA Regulatory Profile
Kentec Medical, Inc appears in FDA public data with 9 recalls, 6 510(k) clearances, 5 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2515-2020, Class II) was initiated on January 17, 2020. Its most recent 510(k) clearance was granted on February 17, 2012.
Summary
- Total Recalls
- 9
- 510(k) Clearances
- 6
- Inspections
- 5
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2515-2020 | Class II | Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Sterile and single use only | January 17, 2020 |
| Z-2520-2020 | Class II | Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Sterile and single use only | January 17, 2020 |
| Z-2519-2020 | Class II | Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Sterile and single use only | January 17, 2020 |
| Z-2517-2020 | Class II | Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Sterile and single use only | January 17, 2020 |
| Z-2518-2020 | Class II | Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Sterile and single use only | January 17, 2020 |
| Z-2514-2020 | Class II | Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Sterile and single use only | January 17, 2020 |
| Z-2516-2020 | Class II | Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Sterile and single use only | January 17, 2020 |
| Z-3073-2017 | Class II | POLYURETHANE ENFit(R) AMERITUS NG FEEDING TUBE, REF Numbers: a) ENF-50P-40 b) ENF-50P-50 c) ENF | June 23, 2017 |
| Z-3074-2017 | Class II | POLYURETHANE ENFit(R) AMERITUS NG FEEDING TUBE, WITH SIDE PORT, REF Numbers: a) ENF-Y50P-40 b) E | June 23, 2017 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K120272 | AMERITUS MEDICAL ENTERAL FEEDING EXTENSION SET | February 17, 2012 |
| K100526 | AMERITUS ENTRAL (TM) ENTERAL FEEDING TUBE | April 22, 2010 |
| K050443 | ACCU-LEAD | September 2, 2005 |
| K970686 | ACCUTEMP-PROBE | August 25, 1997 |
| K960080 | ACCUTEMP PROBE | May 1, 1996 |
| K853475 | GRAM-MA NEONATAL SC | September 5, 1985 |