Amsino International, Inc.
Pomona, CA, US
AMSINO INTERNATIONAL, INC. appears in FDA device records in Pomona, CA. FDA records list 28 510(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 28 510(k) clearances for Amsino International, Inc. between 2002 and 2026. The busiest year on record is 2018, with 5. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2002 | 1 |
| 2003 | 3 |
| 2004 | 1 |
| 2005 | 4 |
| 2006 | 1 |
| 2007 | 1 |
| 2008 | 1 |
| 2009 | 2 |
| 2010 | 3 |
| 2018 | 5 |
| 2019 | 1 |
| 2020 | 1 |
| 2022 | 3 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K252543 | AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF, BA-70071-DF-120, FE01, FE04) | FPA | Substantially Equivalent | |
| K220230 | AMSure Enteral Feeding Pump | LZH | Substantially Equivalent | |
| K220267 | AMSafe NeuFlo Needleless Connector | FPA | Substantially Equivalent | |
| K213522 | AMSafe Pre-Filled Normal Saline Flush Syringe | NGT | Substantially Equivalent | |
| K200051 | PUGGLE Enteral Feeding Pump and Feeding Set | LZH | Substantially Equivalent | |
| K183473 | AMSafe(R) Pre-Filled Normal Saline Flush Syringe | NGT | Substantially Equivalent | |
| K181445 | AMSure Hydrophilic Intermittent Catheter | EZD | Substantially Equivalent | |
| K181423 | AMSure Sterile Water, and Sterile Normal Saline for Wound Flush | FRO | Substantially Equivalent | |
| K173665 | AMSafe Sure-Lok Needle-Free Connector | FPA | Substantially Equivalent | |
| K181814 | AMSure Pre-filled Syringe for Balloon Inflation with Sterile Water | EZL | Substantially Equivalent | |
| K171857 | AMSure® Enteral Feeding Syringe with ENFit Tip | PNR | Substantially Equivalent | |
| K101958 | AMSINO I.V. ADMINISTRATION AND EXTENSION SETS | FPA | Substantially Equivalent | |
| K101824 | AMSURE 3-WAY HYDROPHILIC LATEX FOLEY CATHETER | EZL | Substantially Equivalent | |
| K093773 | AMSINO I.V. ADMINISTRATION SET, AMSAFE3 I.V ADMINISTRATION SET, EXTENSION SETS | FPA | Substantially Equivalent | |
| K091306 | AMSURE PVC INTERMITTENT CATHETER | EZD | Substantially Equivalent | |
| K091699 | AMSURE HYDROPHILIC LATEX FOLEY CATHETER | EZL | Substantially Equivalent | |
| K082831 | AMSELF CLOSED CATHETERIZATION SYSTEM | FCM | Substantially Equivalent | |
| K070411 | AMSURE NEBULIZER | CAF | Substantially Equivalent | |
| K061039 | AMSURE DISPOSABLE SYRINGE WITH/WITHOUT NEEDLE | FMF | Substantially Equivalent | |
| K050785 | AMSINO ENDOTRACHEAL TUBE | BTR | Substantially Equivalent | |
| K051059 | AMSURE 100% SILICONE FOLEY CATHETER | EZL | Substantially Equivalent | |
| K050656 | AMSINO SUTURE REMOVAL KIT | MCZ | Substantially Equivalent | |
| K050654 | AMSINO I.V. START KIT | LRS | Substantially Equivalent | |
| K030293 | AMSURE RED RUBBER URETHRAL CATHETER | EYB | Substantially Equivalent | |
| K030120 | AMSURE FOLEY CATHETER | EZL | Substantially Equivalent | |
| K030712 | AMSURE URETHRAL CATHETERIZATION TRAY | FCM | Substantially Equivalent | |
| K030664 | AMSURE FOLEY INSERTION TRAY | FCM | Substantially Equivalent | |
| K023276 | AMSINO TRACHEOSTOMY CARE TRAY | LRO | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2085175 | 1000160626 | AMSINO INTERNATIONAL, INC. | 708 Corporate Center Dr, POMONA, CA 91768 US | 2026 | No device listings on this registration |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- EZLCatheter, Retention Type, Balloon
- EZDCatheter, Straight
- EYBCatheter, Ureteral, Gastro-Urology
- FRODressing, Wound, Drug
- PNREnteral Syringes With Enteral Specific Connectors
- LROGeneral Surgery Tray
- LRSI.V. Start Kit
- CAFNebulizer (Direct Patient Interface)
- LZHPump, Infusion, Enteral
- NGTSaline, Vascular Access Flush
- FPASet, Administration, Intravascular
- MCZSuture Removal Kit
- FMFSyringe, Piston
- FCMTray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)
- BTRTube, Tracheal (W/Wo Connector)
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