Data / Medical devices / United States / Neotech Products, LLC
Neotech Products, LLC: FDA-registered device maker in Valencia, CA, United States, 3 510(k) clearances
Neotech Products, LLC is registered with the FDA (registration 2025917) in Valencia, CA, United States. It lists 20 device types. The FDA files 3 510(k) clearances under its listings, the newest dated August 27, 2021. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 2025917
- Address
- 28430 Witherspoon Pkwy, Valencia, CA, United States, 91355
- Owner or operator
- Neotech Products LLC (2025917)
- Roles
- Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- September 20, 2004
- Registered through
- 2027
- Brand names listed
- Cannu-Hold, Curved Sucker, Depressor, EZ CARE, EZ Groove, EZ-HOLD, Flow Caddy, HOLD-A-LINE and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bandage, Elastic | FQM | 1 | Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Cannula, Nasal, Oxygen | CAT | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Catheter And Tip, Suction | JOL | 2 | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Catheters, Suction, Tracheobronchial | BSY | 1 | Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Clip, Nose | BXJ | 1 | Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Container, Liquid Medication, Graduated | KYW | 1 | Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Device, Fixation, Tracheal Tube | CBH | 1 | Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Device, Intravascular Catheter Securement | KMK | 1 | Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Electrode, Electrocardiograph | DRX | 2 | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Enteral Syringes With Enteral Specific Connectors | PNR | 2 | Complaint file establishment | accessdata.fda.gov |
| Gastrointestional Tube Holder | PLI | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Pad, Neonatal Eye | FOK | 1 | Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Pump, Breast, Non-Powered | HGY | 1 | Manufacturer | accessdata.fda.gov |
| Specula Accessories | FXG | 1 | Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Support, Breathing Tube | JAY | 1 | Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Support, Patient Position | CCX | 1 | Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Tape And Bandage, Adhesive | KGX | 1 | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Transilluminator, Ac-Powered | HJM | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Transilluminator, Battery-Powered | HJN | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Tubing, Pressure And Accessories | BYX | 1 | Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
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 |
|---|---|---|---|---|---|---|
| August 27, 2021 | K203613 | ENFit Reusable Enteral Syringe | PNR | Substantially Equivalent | Shantou Wealy Medical Instrument Co.,Ltd | accessdata.fda.gov |
| January 3, 2002 | K011564 | NEOLEAD | DRX | Substantially Equivalent | Neotech Products, Inc. | accessdata.fda.gov |
| June 19, 1986 | K862132 | HCI MECONIUM ASPIRATOR | BSY | Substantially Equivalent | Hospital Concepts, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Bandage, Elastic
- All makers of Support, Patient Position
- All makers of Support, Breathing Tube
- All makers of Clip, Nose
- All makers of Catheters, Suction, Tracheobronchial
- All makers of Transilluminator, Ac-Powered
Updated August 27, 2021. 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.