Data / Medical devices / United States / Exelint International, Co.
Exelint International, Co.: FDA-registered device maker in Redondo Beach, CA, United States, 20 510(k) clearances
Exelint International, Co. is registered with the FDA (registration 1035907) in Redondo Beach, CA, United States. It lists 14 device types. The FDA files 20 510(k) clearances under its listings, the newest dated December 12, 2025. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1035907
- Address
- 2500 Santa Fe Avenue, Redondo Beach, CA, United States, 90278
- Owner or operator
- EXELINT INTERNATIONAL, CO. (10024414)
- Roles
- Manufacturer, Specification developer
- First device listed
- September 26, 2014
- Registered through
- 2026
- Brand names listed
- Comfortpoint Insulin Syringe, EXEL 1ml Delivery Syringe, EXEL Aluminum Hub Blunt Needle, EXEL Catheter Tip Syringe, EXEL Curved Tip Syringe, EXEL Disposable Scalpel, EXEL Disposable Syringe, EXEL Disposable Syringe with Needle 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 |
|---|---|---|---|---|---|---|
| December 12, 2025 | K251089 | EXEL Disposable Syringe; EXEL Disposable Syringe with Needle; EXEL Disposable Syringe with Secure Touch® Safety Needle; EXEL Disposable Hypodermic Needle | FMF | Substantially Equivalent | Exelint International, Co. | accessdata.fda.gov |
| November 2, 2015 | K152183 | EXELINT SecureTouch Safety Hypodermic Needle | FMI | Substantially Equivalent | Exelint International, Co. | accessdata.fda.gov |
| October 18, 2012 | K113469 | NIPRO HUBER INFUSION, EXCEL HUBER NEEDLE | FMI | Substantially Equivalent | Nipro Medical Corporation | accessdata.fda.gov |
| October 17, 2012 | K113470 | NIPRO SAFE TOUCH HUBER INFUSION SET | FPA | Substantially Equivalent | Nipro Medical Corporation | accessdata.fda.gov |
| October 20, 2010 | K101309 | EXELINT ALUMINUM HUB BLUNT NEEDLES | LHI | Substantially Equivalent | Exelint International, Co. | accessdata.fda.gov |
| January 4, 2010 | K092172 | EXEL I.V. EXTENSION SET | FPA | Substantially Equivalent | Exelint Intl. Co. | accessdata.fda.gov |
| October 19, 2005 | K052103 | EXEL SECURE TOUCH II SAFETY SYRINGE | MEG | Substantially Equivalent | Exelint Intl. Co. | accessdata.fda.gov |
| July 25, 2003 | K031500 | EXCEL PRIMARY SOLUTION SET | FPA | Substantially Equivalent | Exelint Intl. Co. | accessdata.fda.gov |
| March 27, 2003 | K020189 | EXEL BUTTERFLY SCALP VEIN SET | FPA | Substantially Equivalent | Exelint International, Co. | accessdata.fda.gov |
| December 2, 2002 | K020533 | EXEL VACULET BLOOD COLLECTION SET | FPA | Substantially Equivalent | Exelint Intl. Co. | accessdata.fda.gov |
| January 17, 2002 | K012879 | EXEL HUBER INFUSION SET WITH NEEDLELESS INJECTION SITE | FPA | Substantially Equivalent | Exelint Intl. Co. | accessdata.fda.gov |
| September 27, 2001 | K011405 | EXEL INJECTION PLUG WITH CAP | FPA | Substantially Equivalent | Exelint Intl. Co. | accessdata.fda.gov |
| August 30, 2001 | K010404 | EXEL I.V. ADMINISTRATION SET | FPA | Substantially Equivalent | Exelint Intl. Co. | accessdata.fda.gov |
| May 14, 2001 | K010197 | EXEL SECURE TOUCH SAFETY (P.S.V.) SCALP VEIN SET | FPA | Substantially Equivalent | Exelint International, Co. | accessdata.fda.gov |
| November 21, 1990 | K904685 | EXEL HUBER INFUSION SET WITHOUT INJECTION SITE (Y) | FPA | Substantially Equivalent | Exel Intl. | accessdata.fda.gov |
| February 16, 1990 | K895771 | EXEL SPINAL NEEDLES | FMI | Substantially Equivalent | Exel Intl. | accessdata.fda.gov |
| February 16, 1990 | K895768 | EXEL SAFELET CATHETER | FOZ | Substantially Equivalent | Exel Intl. | accessdata.fda.gov |
| May 6, 1986 | K861152 | EXEL VACUUM BLOOD COLLECTING SYSTEM | FMI | Substantially Equivalent | Exel Intl. | accessdata.fda.gov |
| April 23, 1986 | K861153 | DISPOSABLE SYRINGES AND HYPODERMIC NEEDLES | FMF | Substantially Equivalent | Exel Intl. | accessdata.fda.gov |
| April 11, 1986 | K861150 | EXEL DENTAL NEEDLE | DZM | Substantially Equivalent | Exel Intl. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| December 23, 2009 | 54203 | Not yet classified | Terminated | Exel Huber Needles (Right angle and Straight Models with Catalog Numbers: 26901CE, 26902CE, 26903CE, 26904CE, 26905CE, 26906CE, 26907CE, 26908CE, 26909CE, 26910CE, 26911CE, 26921CE, 26922CE, 26923CE, 26924CE, 26925CE, 26 | Non-coring needles that, when inserted into an implanted port, were shown to core the silicone port's septum. Coring of port's septum may lead to: decreased effectiveness of port, infection, necrosis, swelling, and embolization, which may result in pulmonary embolism, limb ischemia, stroke, local extravasation of medication such as chemotherapy or other caus | accessdata.fda.gov |
Compare with other makers
- All makers of Syringe, Irrigating (Non Dental)
- All makers of Set, I.V. Fluid Transfer
- All makers of Set, Administration, Intravascular
- All makers of Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
- All makers of Syringe, Antistick
- All makers of Needle, Hypodermic, Single Lumen
Updated December 12, 2025. 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.