510(k) Report

FDA applicant

Amsino International, Inc.

Pomona, CA28 decisions2002–20260 recalls

FDA records 28 decisions for Amsino International, Inc. (Pomona, CA) from 2002 to 2026: 28 510(k) clearances. Most are in product codes EZL (Catheter, Retention Type, Balloon) and FPA (Set, Administration, Intravascular). Since 2016 its 510(k)s took a median of 194 days from receipt to decision, against 177 for FDA’s reviews in the same codes and years. Its devices cite 29 predicates, 8 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, gastroenterology and urology panel, where it files most

How often FDA has decided Amsino International, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

3in 2022

2007: 12008: 12009: 22010: 32018: 52019: 12020: 12022: 32026 (partial year): 1
2007high 5 (2018) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Amsino International, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Amsino International, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • EZLCatheter, Retention Type, Balloon5decisions
  • FPASet, Administration, Intravascular5decisions
  • FCMTray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)3decisions
  • NGTSaline, Vascular Access Flush2decisions
  • LZHPump, Infusion, Enteral2decisions
  • EZDCatheter, Straight2decisions

Also: BTR (1), FRO (1), LRO (1), LRS (1), CAF (1), MCZ (1).

How long do its 510(k) reviews take?

Since 2016, its 8 510(k)s took a median of 194 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 177 days; 4 of its 8 were faster than that.

Whose devices does it build on?

Its devices cite 29 predicates; 8 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 15 times; 8 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K183473AMSafe (R) Pre-Filled Normal Saline Flush SyringeAmsino International, Inc. · 20192cite it
  • K030712Amsure Urethral Catheterization TrayAmsino International, Inc. · 20032cite it
  • K091699Amsure Hydrophilic Latex Foley CatheterAmsino International, Inc. · 20092cite it
  • K213522AMSafe Pre-Filled Normal Saline Flush SyringeAmsino International, Inc. · 20222cite it
  • K030120Amsure Foley CatheterAmsino International, Inc. · 20032cite it
  • K181814AMSure Pre-filled Syringe for Balloon Inflation with Sterile WaterAmsino International, Inc. · 20181cites it

What has FDA decided for it lately?

  • K252543AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF…Amsino International, Inc. · 2026
  • K220230AMSure Enteral Feeding PumpAmsino International, Inc. · 2022
  • K220267AMSafe NeuFlo Needleless ConnectorAmsino International, Inc. · 2022
  • K213522AMSafe Pre-Filled Normal Saline Flush SyringeAmsino International, Inc. · 2022
  • K200051PUGGLE Enteral Feeding Pump and Feeding SetAmsino International, Inc. · 2020
  • K183473AMSafe (R) Pre-Filled Normal Saline Flush SyringeAmsino International, Inc. · 2019
  • K181445AMSure Hydrophilic Intermittent CatheterAmsino International, Inc. · 2018
  • K181423AMSure Sterile Water, and Sterile Normal Saline for Wound FlushAmsino International, Inc. · 2018

All 28 as Amsino International, Inc. →

Other applicant names beginning “Amsino”

FDA records each applicant name separately; these may or may not be the same firm.

Amsino Intl., Inc. 9Amsino Medical, Inc. 1