Kawasumi Laboratories Co., Ltd.: FDA filings under this applicant name
FDA lists 29 510(k) clearances under the applicant name “Kawasumi Laboratories Co., Ltd.” (first 1987, latest 2019), across 13 product codes in 4 review panels. Median 510(k) review time under this name: 127 days. Since 2017 the median was 131 days, against 190 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 | 1 | 127 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 1 | 367 |
| 2019 | 2 | 108 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Kawasumi Laboratories Co., Ltd. took a median 131 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 190 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FPA | Set, Administration, Intravascular | 10 | 10 |
| FMI | Needle, Hypodermic, Single Lumen | 5 | 5 |
| LJT | Port & Catheter, Implanted, Subcutaneous, Intravascular | 4 | 4 |
| FJI | Dialyzer, Capillary, Hollow Fiber | 1 | 1 |
| FJK | Set, Tubing, Blood, With And Without Anti-Regurgitation Valve | 1 | 1 |
| FKQ | System, Dialysate Delivery, Central Multiple Patient | 1 | 1 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 1 | 1 |
| FRN | Pump, Infusion | 1 | 1 |
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | 1 | 1 |
| KPE | Container, I.V. | 1 | 1 |
Plus 3 more product codes.
Review panels
Most recent Kawasumi Laboratories Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K190485 | Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH) | JKA | 2019-07-08 | 131 |
| K190233 | K-Shield Advantage Port Access Infusion Set (PAIS) | FPA | 2019-05-02 | 85 |
| K172957 | Kawasumi Laboratories Blood Drawing Kit (BDK) System | KSB | 2018-09-28 | 367 |
| K123344 | K-SHIELD ADVANTAGE PORT ACCESS INFUSION SET (PAIS) | FPA | 2013-03-07 | 127 |
| K100720 | K-SHIELD PORT ACCESS INFUSION SET WITH HIGH PRESSURE TUBING | FPA | 2010-11-18 | 248 |
| K102994 | K-SHIELD ARTERIAL VENOUS FISTULA SET WITH ANTINEEDLE STICK PROTECTOR | FMI | 2010-11-03 | 26 |
| K073257 | KAWASUMI LABORATORIES LARGE WING SETS WITH ANTINEEDLE STICK PROTECTOR | FMI | 2008-01-25 | 67 |
| K061197 | KAWASUMI LABORATORIES EMPTY SOLUTION CONTAINER | KPE | 2006-06-30 | 63 |
| K060580 | K-SHIELD PORT ACCESS INFUSION SET | FPA | 2006-06-06 | 92 |
| K023917 | WINGED NEEDLE SETS WITH AN ANTINEEDLE STICK PROTECTOR | FPA | 2003-02-26 | 93 |
19 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Kawasumi Laboratories Co., Ltd..
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 Kawasumi Laboratories Co., Ltd. (a text match, not an official crosswalk):
- A4220 — Refill kit for implantable infusion pump (via FRN)
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via FRN)
- E0785 — Implantable intraspinal (epidural/intrathecal) catheter used with implantable infusion pump, replacement (via FRN)
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 America, Inc. (6 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Kawasumi Laboratories Co., Ltd.?
FDA lists 29 510(k) clearances under the applicant name “Kawasumi Laboratories Co., Ltd.” (first 1987, latest 2019), across 13 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 Kawasumi Laboratories Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Kawasumi Laboratories Co., Ltd. is 127 days. Since 2017: 131 days, versus 190 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Kawasumi Laboratories Co., Ltd.?
The most frequent FDA product codes under this applicant name are FPA (Set, Administration, Intravascular, 10); FMI (Needle, Hypodermic, Single Lumen, 5); LJT (Port & Catheter, Implanted, Subcutaneous, Intravascular, 4).
Next steps
- See all 29 Kawasumi Laboratories Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code FPA, Kawasumi Laboratories Co., Ltd.'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.