Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Amsino International, Inc. · Predicate Candidate Screening
28 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
109 daysmedian FDA review time
287 days90th percentile
28clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252543 | AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, B | Amsino International, Inc. | 2026-05-04 | 265 | 0 |
| K220230 | AMSure Enteral Feeding Pump | Amsino International, Inc. | 2022-11-10 | 287 | 0 |
| K220267 | AMSafe NeuFlo Needleless Connector | Amsino International, Inc. | 2022-10-07 | 249 | 0 |
| K213522 | AMSafe Pre-Filled Normal Saline Flush Syringe | Amsino International, Inc. | 2022-03-22 | 139 | 0 |
| K200051 | PUGGLE Enteral Feeding Pump and Feeding Set | Amsino International, Inc. | 2020-09-25 | 259 | 0 |
| K183473 | AMSafe(R) Pre-Filled Normal Saline Flush Syringe | Amsino International, Inc. | 2019-07-12 | 210 | 0 |
| K181445 | AMSure Hydrophilic Intermittent Catheter | Amsino International, Inc. | 2018-10-01 | 122 | 0 |
| K181423 | AMSure Sterile Water, and Sterile Normal Saline for Wound Fl | Amsino International, Inc. | 2018-09-07 | 99 | 0 |
| K173665 | AMSafe Sure-Lok Needle-Free Connector | Amsino International, Inc. | 2018-09-05 | 280 | 0 |
| K181814 | AMSure Pre-filled Syringe for Balloon Inflation with Sterile | Amsino International, Inc. | 2018-09-04 | 57 | 0 |
| K171857 | AMSure® Enteral Feeding Syringe with ENFit Tip | Amsino International, Inc. | 2018-03-30 | 282 | 0 |
| K101958 | AMSINO I.V. ADMINISTRATION AND EXTENSION SETS | Amsino International, Inc. | 2010-09-29 | 79 | 0 |
| K101824 | AMSURE 3-WAY HYDROPHILIC LATEX FOLEY CATHETER | Amsino International, Inc. | 2010-09-13 | 74 | 0 |
| K093773 | AMSINO I.V. ADMINISTRATION SET, AMSAFE3 I.V ADMINISTRATION S | Amsino International, Inc. | 2010-03-10 | 92 | 0 |
| K091306 | AMSURE PVC INTERMITTENT CATHETER | Amsino International, Inc. | 2009-08-21 | 109 | 0 |
| K091699 | AMSURE HYDROPHILIC LATEX FOLEY CATHETER | Amsino International, Inc. | 2009-08-10 | 61 | 0 |
| K082831 | AMSELF CLOSED CATHETERIZATION SYSTEM | Amsino International, Inc. | 2008-10-23 | 27 | 0 |
| K070411 | AMSURE NEBULIZER | Amsino International, Inc. | 2007-10-01 | 231 | 0 |
| K061039 | AMSURE DISPOSABLE SYRINGE WITH/WITHOUT NEEDLE | Amsino International, Inc. | 2006-06-29 | 76 | 0 |
| K050785 | AMSINO ENDOTRACHEAL TUBE | Amsino International, Inc. | 2005-07-15 | 109 | 0 |
| K051059 | AMSURE 100% SILICONE FOLEY CATHETER | Amsino International, Inc. | 2005-06-28 | 63 | 0 |
| K050654 | AMSINO I.V. START KIT | Amsino International, Inc. | 2005-05-02 | 49 | 0 |
| K050656 | AMSINO SUTURE REMOVAL KIT | Amsino International, Inc. | 2005-05-02 | 49 | 0 |
| K030293 | AMSURE RED RUBBER URETHRAL CATHETER | Amsino International, Inc. | 2004-02-04 | 372 | 0 |
| K030120 | AMSURE FOLEY CATHETER | Amsino International, Inc. | 2003-10-29 | 289 | 0 |
| K030712 | AMSURE URETHRAL CATHETERIZATION TRAY | Amsino International, Inc. | 2003-05-23 | 78 | 0 |
| K030664 | AMSURE FOLEY INSERTION TRAY | Amsino International, Inc. | 2003-05-23 | 81 | 0 |
| K023276 | AMSINO TRACHEOSTOMY CARE TRAY | Amsino International, Inc. | 2002-12-09 | 69 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda