Kawasumi Laboratories America, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Kawasumi Laboratories America, Inc.” (first 2000, latest 2010), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 73 days. 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 | 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 |
|---|---|---|---|
| FPA | Set, Administration, Intravascular | 5 | 5 |
| KSB | Set, Transfer (Blood/Plasma) | 1 | 1 |
Review panels
- General Hospital (5)
- Hematology (1)
Most recent Kawasumi Laboratories America, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K102890 | K-SHIELD SMALL VEIN INFUSION / WINGED COLLECTION SET W/ ANTI NEEDLE STICK PROTECTOR (AND MULTISAMPLE LUER ADAPTER) | FPA | 2010-10-21 | 21 |
| K030385 | IV ADD-ON FILTER ADMINISTRATION SET WITH AND WITHOUT Y CONNECT OR NEEDLELESS ACCESS CONNECTOR | FPA | 2003-04-15 | 69 |
| K001426 | KAWASUMI LABORATORIES IV ADMINISTRATION SET WITH FILTER | FPA | 2000-07-21 | 77 |
| K001424 | KAWASUMI LABORATORIES IV ADMINISTRATION SET, STANDARD | FPA | 2000-07-21 | 77 |
| K001423 | KAWASUMI LABORATORIES IV ADMINISTRATION SET, PRIMARY | FPA | 2000-07-21 | 77 |
| K001043 | KAWASUMI LABORATORY BLOOD DRAWING KIT | KSB | 2000-05-19 | 49 |
Recalls
openFDA lists no recalls under a recalling firm named Kawasumi Laboratories America, 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.
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.
- Kawasumi Laboratories Co., Ltd. (29 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Kawasumi Laboratories America, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Kawasumi Laboratories America, Inc.” (first 2000, latest 2010), across 2 product codes in 2 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 Kawasumi Laboratories America, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Kawasumi Laboratories America, Inc. is 73 days.
Which FDA product codes appear under Kawasumi Laboratories America, Inc.?
The most frequent FDA product codes under this applicant name are FPA (Set, Administration, Intravascular, 5); KSB (Set, Transfer (Blood/Plasma), 1).
Next steps
- See all 6 Kawasumi Laboratories America, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FPA, Kawasumi Laboratories America, 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.