Amsino Intl., Inc.: FDA clearances and approvals
Amsino Intl., Inc. has 9 FDA 510(k) clearances (first 1995, latest 2007), across 8 product codes in 4 review panels. Median 510(k) review time: 71 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KNX | Collector, Urine, (And Accessories) For Indwelling Catheter | 2 | 2 |
| BSY | Catheters, Suction, Tracheobronchial | 1 | 1 |
| FCE | Enema Kit | 1 | 1 |
| FPA | Set, Administration, Intravascular | 1 | 1 |
| HHT | Spatula, Cervical, Cytological | 1 | 1 |
| HIB | Speculum, Vaginal, Nonmetal | 1 | 1 |
| KNT | Tubes, Gastrointestinal (And Accessories) | 1 | 1 |
| LJH | System, Irrigation, Urological | 1 | 1 |
Review panels
Most recent Amsino Intl., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K070873 | AMSURE BLADDER IRRIGATION SET | LJH | 2007-12-19 | 265 |
| K992719 | AMSURE ENTERAL DELIVERY PUMP SET WITH SPIKE | KNT | 2000-01-12 | 153 |
| K974042 | AMSURE CLEANSING ENEMA SET | FCE | 1997-12-19 | 56 |
| K973107 | AMSINO I.V. ADMINISTRATION SET | FPA | 1997-10-02 | 44 |
| K973199 | AMSINO SUCTION CATHETER | BSY | 1997-09-10 | 15 |
| K971929 | AMSINO URINARY LEG BAG | KNX | 1997-08-06 | 71 |
| K964745 | AMSINO URINARY DRAINAGE BAG | KNX | 1997-03-18 | 112 |
| K950780 | AMSINO CERVICAL SCRAPER | HHT | 1995-07-25 | 154 |
| K951528 | AMSINO DISPOSABLE VIGINAL SPECULUM | HIB | 1995-05-11 | 38 |
Recalls
openFDA lists no recalls under a recalling firm named Amsino Intl., Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Amsino Intl., Inc. have?
Amsino Intl., Inc. has 9 FDA 510(k) clearances (first 1995, latest 2007), across 8 product codes in 4 review panels.
How long does FDA take to clear Amsino Intl., Inc.'s 510(k)s?
The median time from FDA receipt to decision across Amsino Intl., Inc.'s cleared 510(k)s is 71 days.
What devices does Amsino Intl., Inc. make?
Its most frequent FDA product codes are KNX (Collector, Urine, (And Accessories) For Indwelling Catheter, 2); BSY (Catheters, Suction, Tracheobronchial, 1); FCE (Enema Kit, 1).
Has Amsino Intl., Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Amsino Intl., Inc. Related entities may recall under other names.
Next steps
- See all 9 Amsino Intl., Inc. clearances with predicates and recalls
- Run predicate analysis for product code KNX, Amsino Intl., Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.