# Amsino International, Inc.

- Location (FDA's records): Pomona, CA
- FDA decisions: 28 (2002–2026): 28 510(k) clearances
- Product codes: EZL (5), FPA (5), FCM (3), NGT (2), LZH (2), EZD (2), BTR (1), FRO (1), LRO (1), LRS (1), CAF (1), MCZ (1)
- 510(k) review time since 2016: median 194 days, against 177 for FDA's reviews in the same codes and years (4 of 8 faster)
- Predicates its devices cite: 29 (8 its own); citations of its devices by later devices: 15 (8 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- C.R. Bard, Inc.: 3 (https://510kreport.com/company/cr-bard)
- Amsino Intl., Inc.: 2 (https://510kreport.com/company/amsino-intl)
- Covidien: 2 (https://510kreport.com/company/covidien)
- Am USA: 1 (https://510kreport.com/company/am-usa)
- Primary Care Solutions, Inc.: 1 (https://510kreport.com/company/primary-care-solutions)
- Well Lead Medical Instruments: 1 (https://510kreport.com/company/well-lead-medical-instruments)
- The Kipp Group: 1 (https://510kreport.com/company/kipp-group)
- Icu Medical, Inc.: 1 (https://510kreport.com/company/icu-medical)

## Firms that cite its devices most
- Anhui Tianyang Pharmaceutical Co., Ltd.: 1 (https://510kreport.com/company/anhui-tianyang-pharmaceutical)
- Shandong Ande Healthcare Apparatus Co., Ltd.: 1 (https://510kreport.com/company/shandong-ande-healthcare-apparatus)
- Spm Medicare Pvt., Ltd.: 1 (https://510kreport.com/company/spm-medicare-pvt)
- Chief Medical, LLC: 1 (https://510kreport.com/company/chief-medical)
- Hantech Medical Device Co., Ltd.: 1 (https://510kreport.com/company/hantech-medical-device)
- H R Pharmaceuticals, Inc.: 1 (https://510kreport.com/company/h-r-pharmaceuticals)
- Teleflexmedical, Inc.: 1 (https://510kreport.com/company/teleflexmedical)

## Its most-cited devices
- K183473: AMSafe (R) Pre-Filled Normal Saline Flush Syringe (2019), cited by 2
- K030712: Amsure Urethral Catheterization Tray (2003), cited by 2
- K091699: Amsure Hydrophilic Latex Foley Catheter (2009), cited by 2
- K213522: AMSafe Pre-Filled Normal Saline Flush Syringe (2022), cited by 2
- K030120: Amsure Foley Catheter (2003), cited by 2
- K181814: AMSure Pre-filled Syringe for Balloon Inflation with Sterile Water (2018), cited by 1

## Recent decisions
- 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) (May 4, 2026)
- K220230: AMSure Enteral Feeding Pump (Nov 10, 2022)
- K220267: AMSafe NeuFlo Needleless Connector (Oct 7, 2022)
- K213522: AMSafe Pre-Filled Normal Saline Flush Syringe (Mar 22, 2022)
- K200051: PUGGLE Enteral Feeding Pump and Feeding Set (Sep 25, 2020)
- K183473: AMSafe (R) Pre-Filled Normal Saline Flush Syringe (Jul 12, 2019)
- K181445: AMSure Hydrophilic Intermittent Catheter (Oct 1, 2018)
- K181423: AMSure Sterile Water, and Sterile Normal Saline for Wound Flush (Sep 7, 2018)

Source page: https://510kreport.com/company/amsino-international