Neotech Products, LLC
Valencia, CA, US
NEOTECH PRODUCTS, LLC appears in FDA device records in Valencia, CA. FDA records list 6 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 6 510(k) clearances for Neotech Products, LLC between 1988 and 2002. The busiest year on record is 1988, with 2. The most recent is 2002, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1988 | 2 |
| 1989 | 1 |
| 1992 | 1 |
| 1993 | 1 |
| 2002 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K011564 | NEOLEAD | DRX | Substantially Equivalent | |
| K931727 | URINARY DRAINAGE BAG CADDY | FAQ | Substantially Equivalent | |
| K921024 | URO-TOTE LEG BAG | KNX | Substantially Equivalent | |
| K890425 | NEOTECH MUCUS TRAP W/CATHETER | BSY | Substantially Equivalent | |
| K882203 | NEOTECH UNIVERSAL ADAPTER | BZA | Substantially Equivalent | |
| K880487 | NEOTECH MECONIUM ASPIRATOR (STERILE) | BTR | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2025917 | 2025917 | NEOTECH PRODUCTS, LLC | 28430 Witherspoon Pkwy, Valencia, CA 91355 US | 2026 | and 10 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- FAQBag, Urine Collection, Leg, For External Use, Sterile
- FQMBandage, Elastic
- CATCannula, Nasal, Oxygen
- JOLCatheter And Tip, Suction
- BSYCatheters, Suction, Tracheobronchial
- BXJClip, Nose
- KNXCollector, Urine, (And Accessories) For Indwelling Catheter
- BZAConnector, Airway (Extension)
- KYWContainer, Liquid Medication, Graduated
- CBHDevice, Fixation, Tracheal Tube
- KMKDevice, Intravascular Catheter Securement
- DRXElectrode, Electrocardiograph
- PNREnteral Syringes With Enteral Specific Connectors
- PLIGastrointestional Tube Holder
- FOKPad, Neonatal Eye
- HGYPump, Breast, Non-Powered
- FXGSpecula Accessories
- JAYSupport, Breathing Tube
- CCXSupport, Patient Position
- KGXTape And Bandage, Adhesive
- HJMTransilluminator, Ac-Powered
- HJNTransilluminator, Battery-Powered
- BTRTube, Tracheal (W/Wo Connector)
- BYXTubing, Pressure And Accessories
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain