Data / Medical devices / United States / Kentec Medical, LLC
Kentec Medical, LLC: FDA-registered device maker in Irvine, CA, United States, 6 510(k) clearances
Kentec Medical, LLC is registered with the FDA (registration 2080225) in Irvine, CA, United States. It lists 12 device types. The FDA files 6 510(k) clearances under its listings, the newest dated January 18, 2019. 3 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 3, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 2080225
- Address
- 17871 Fitch, Irvine, CA, United States, 92614
- Owner or operator
- KENTEC MEDICAL, INC. (2080225)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- February 7, 2006
- Registered through
- 2026
- Brand names listed
- ACCU-BOARD, Accutemp(r), Ameritus ENFit enteral feeding tube(vr), Ameritus ENFit(r) Enteral Syringes, Ameritus Enteral Extension Set, Ameritus Entral(tm) Feeding Tube, Ameritus Oral Syringe(GB), Ameritus push-in Bottle Adapter(GB), Ameritus(R) Milk Straw and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 18, 2019 | K180236 | VR Medical Feeding Tube and Enteral Feeding Extension Set (EFES) | FPD | Substantially Equivalent | Vr Medical Technology Co., Ltd. | accessdata.fda.gov |
| September 22, 2016 | K162188 | Enteral Syringe with ENFit Connector (10 ml to 60 ml), Enteral Syringe with ENFit Low Dose Tip (1 ml to 5 ml) | PNR | Substantially Equivalent | Vr Medical Technology | accessdata.fda.gov |
| February 17, 2012 | K120272 | AMERITUS MEDICAL ENTERAL FEEDING EXTENSION SET | KNT | Substantially Equivalent | Kentec Medical, Inc. | accessdata.fda.gov |
| May 13, 2011 | K110853 | VR MEDICAL ENTERAL ORAL SYRINGE | FPD | Substantially Equivalent | Vr Medical | accessdata.fda.gov |
| April 22, 2010 | K100526 | AMERITUS ENTRAL (TM) ENTERAL FEEDING TUBE | FPD | Substantially Equivalent | Kentec Medical, Inc. | accessdata.fda.gov |
| September 2, 2005 | K050443 | ACCU-LEAD | DRX | Substantially Equivalent | Kentec Medical, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| January 17, 2020 | 85430 | Class II | Terminated | 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). | Feeding tube plastic tethered closure cap may possibly fracture or break. Possible health hazards: (1) Enteral feeding and medication administration could be possibly delayed, until replacement tube is placed into patient (2) Patient could be unnecessarily overexposed to radiation if multiple x-rays are needed to confirm placement of a new tube, if x-ray is | accessdata.fda.gov |
| June 23, 2017 | 77729 | Class II | Terminated | 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) ENF-100P-110 For pediatric and | Inadequate detectability of radiopaque stripes | accessdata.fda.gov |
| May 18, 2007 | 46397 | Not yet classified | Terminated | 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 | Incompatible components: The Finger Clip Sensors - with a Serial Number prefix of PA514, PA515, YE508, ZC502 and ZG512 - are missing an additional diode and higher resistor in its existing configuration making them inoperable when used to interface with those Ohmeda Tuffsat monitors previously re-configured by Ohmeda to include a detection circuit for diodes | accessdata.fda.gov |
Compare with other makers
- All makers of Applicator, Absorbent Tipped, Non-Sterile
- All makers of Electrode, Electrocardiograph
- All makers of System, Blood Collection, Vacuum-Assisted, Manual
- All makers of Tube, Feeding
- All makers of Utensil, Eating
- All makers of Enteral Syringes With Enteral Specific Connectors
Updated January 18, 2019. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.