Amsino International, Inc.: FDA filings under this applicant name
FDA lists 28 510(k) clearances under the applicant name “Amsino International, Inc.” (first 2002, latest 2026), across 15 product codes in 4 review panels. Median 510(k) review time under this name: 104 days. Since 2017 the median was 249 days, against 209 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 5 | 122 |
| 2019 | 1 | 210 |
| 2020 | 1 | 259 |
| 2021 | 0 | — |
| 2022 | 3 | 249 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 1 | 265 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Amsino International, Inc. took a median 249 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 209 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| EZL | Catheter, Retention Type, Balloon | 5 | 5 |
| FPA | Set, Administration, Intravascular | 5 | 5 |
| FCM | Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit) | 3 | 3 |
| EZD | Catheter, Straight | 2 | 2 |
| LZH | Pump, Infusion, Enteral | 2 | 2 |
| NGT | Saline, Vascular Access Flush | 2 | 2 |
| BTR | Tube, Tracheal (W/Wo Connector) | 1 | 1 |
| CAF | Nebulizer (Direct Patient Interface) | 1 | 1 |
| EYB | Catheter, Ureteral, Gastro-Urology | 1 | 1 |
| FMF | Syringe, Piston | 1 | 1 |
Plus 5 more product codes.
Review panels
- Gastroenterology and Urology (12)
- General Hospital (10)
- General and Plastic Surgery (4)
- Anesthesiology (2)
Most recent Amsino International, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| 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 | 2026-05-04 | 265 |
| K220230 | AMSure Enteral Feeding Pump | LZH | 2022-11-10 | 287 |
| K220267 | AMSafe NeuFlo Needleless Connector | FPA | 2022-10-07 | 249 |
| K213522 | AMSafe Pre-Filled Normal Saline Flush Syringe | NGT | 2022-03-22 | 139 |
| K200051 | PUGGLE Enteral Feeding Pump and Feeding Set | LZH | 2020-09-25 | 259 |
| K183473 | AMSafe(R) Pre-Filled Normal Saline Flush Syringe | NGT | 2019-07-12 | 210 |
| K181445 | AMSure Hydrophilic Intermittent Catheter | EZD | 2018-10-01 | 122 |
| K181423 | AMSure Sterile Water, and Sterile Normal Saline for Wound Flush | FRO | 2018-09-07 | 99 |
| K173665 | AMSafe Sure-Lok Needle-Free Connector | FPA | 2018-09-05 | 280 |
| K181814 | AMSure Pre-filled Syringe for Balloon Inflation with Sterile Water | EZL | 2018-09-04 | 57 |
18 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Amsino International, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Amsino International, Inc. (a text match, not an official crosswalk):
- A4220 — Refill kit for implantable infusion pump (via LZH)
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via LZH)
- G0379 — Direct admission of patient for hospital observation care (via CAF)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Amsino Intl., Inc. (9 510(k)s)
- Amsino Medical, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Amsino International, Inc.?
FDA lists 28 510(k) clearances under the applicant name “Amsino International, Inc.” (first 2002, latest 2026), across 15 product codes in 4 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Amsino International, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Amsino International, Inc. is 104 days. Since 2017: 249 days, versus 209 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Amsino International, Inc.?
The most frequent FDA product codes under this applicant name are EZL (Catheter, Retention Type, Balloon, 5); FPA (Set, Administration, Intravascular, 5); FCM (Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit), 3).
Next steps
- See all 28 Amsino International, Inc. clearances with predicates and recalls
- Run predicate analysis for product code EZL, Amsino International, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.