Company ยท US
Kentec Medical, Inc
FDA 510(k) clearances and medical device recalls filed under this name, 1985 to 2012. Name variants (Inc, Corp, punctuation) are merged.
6510(k) clearances (0 in 12 months)
10recalls (0 in 12 months)
10recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 17, 2012 | K120272 | AMERITUS MEDICAL ENTERAL FEEDING EXTENSION SET Kentec Medical, Inc. | KNT |
| Apr 22, 2010 | K100526 | AMERITUS ENTRAL (TM) ENTERAL FEEDING TUBE Kentec Medical, Inc. | FPD |
| Sep 2, 2005 | K050443 | ACCU-LEAD Kentec Medical, Inc. | DRX |
| Aug 25, 1997 | K970686 | ACCUTEMP-PROBE Kentec Medical, Inc. | FMT |
| May 1, 1996 | K960080 | ACCUTEMP PROBE Kentec Medical, Inc. | FMT |
| Sep 5, 1985 | K853475 | GRAM-MA NEONATAL SC Kentec Medical, Inc. | FRW |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 17, 2020 | Kentec Medical, Inc Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Sterile and single use only. Catalog number ENF-Y60P-80 (6 fr. 80 cm ENFit Enteral Feeding Tube with Y-Port). Terminated |
FPD | K100526 |
| Jan 17, 2020 | Kentec Medical, Inc Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Sterile and single use only. Catalog number ENF-Y50P-80 (5 fr. 80 cm ENFit Enteral Feeding Tube with Y-Port). Terminated |
FPD | K100526 |
| Jan 17, 2020 | Kentec Medical, Inc Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Sterile and single use only. Catalog number ENF-Y60P-50 (6 fr. 50 cm ENFit Enteral Feeding Tube with Y-Port). Terminated |
FPD | K100526 |
| Jan 17, 2020 | Kentec Medical, Inc Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Sterile and single use only. Catalog number ENF-80P-50 (8 fr. 50 cm ENFit Enteral Feeding Tube). Terminated |
FPD | K100526 |
| Jan 17, 2020 | Kentec Medical, Inc Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Sterile and single use only. Catalog number ENF-60P-50 (6 fr. 50 cm ENFit Enteral Feeding Tube). Terminated |
FPD | K100526 |
| Jan 17, 2020 | Kentec Medical, Inc Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Sterile and single use only. Catalog number ENF-50P-50 (5 fr. 50 cm ENFit Enteral Feeding Tube). Terminated |
FPD | K100526 |
| Jan 17, 2020 | Kentec Medical, Inc Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Sterile and single use only. Catalog number ENF-40P-50 (4 fr. 50 cm ENFit Enteral Feeding Tube). Terminated |
FPD | K100526 |
| Jul 22, 2017 | Kentec Medical Inc POLYURETHANE ENFit(R) AMERITUS NG FEEDING TUBE, WITH SIDE PORT, REF Numbers:
a) ENF-Y50P-40
b) ENF-Y50P-50
c) ENF-Y60P-40
d) ENF-Y60P-50
e) ENF-Y60P-90
f) ENF-Y80P-40
g) ENF-Y80P-50
h) ENF-Y Terminated |
FPD | K100526 |
| Jul 22, 2017 | Kentec Medical Inc POLYURETHANE ENFit(R) AMERITUS NG FEEDING TUBE, REF Numbers:
a) ENF-50P-40
b) ENF-50P-50
c) ENF-50P-80
d) ENF-60P-40
e) ENF-60P-50
f) ENF-60P-80
g) ENF-80P-40
h) ENF-80P-50
i) ENF-80P-80
j Terminated |
FPD | K100526 |
| Jun 26, 2008 | Kentec Medical Inc Reusable Ohmeda Compatible Finger Clip Sensor, Model Number: E403-02, Product Code: PS2225. To monitor oxygen saturation level of patients under doctor's care. Kentec Medical Inc., Irvine, CA 92614 Terminated |
DQA | K970098 |