Sb-Kawasumi Laboratories, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Sb-Kawasumi Laboratories, Inc.” (first 2022, latest 2025), across 3 product codes in 3 review panels. Median 510(k) review time under this name: 120 days. Since 2017 the median was 120 days, against 177 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 |
|---|---|---|
| 2022 | 1 | 164 |
| 2023 | 2 | 86 |
| 2024 | 0 | — |
| 2025 | 2 | 196 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Sb-Kawasumi Laboratories, Inc. took a median 120 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 177 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | 3 | 3 |
| KNS | Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | 1 | 1 |
| PTI | Non-Coring (Huber) Needle | 1 | 1 |
Review panels
Most recent Sb-Kawasumi Laboratories, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K252355 | K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure Tubing | PTI | 2025-11-26 | 120 |
| K241855 | SB Knife Jr2 (MD-47702 and MD-47702L) | KNS | 2025-03-26 | 272 |
| K230408 | K-SHIELD Zen (Model Numbers: PBMH/ PBMA/ PBM) | JKA | 2023-06-01 | 106 |
| K223810 | Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH) | JKA | 2023-02-24 | 66 |
| K220799 | K-SHIELD Zen | JKA | 2022-08-29 | 164 |
Recalls
openFDA lists no recalls under a recalling firm named Sb-Kawasumi Laboratories, 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Sb-Kawasumi Laboratories, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Sb-Kawasumi Laboratories, Inc.” (first 2022, latest 2025), across 3 product codes in 3 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 Sb-Kawasumi Laboratories, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Sb-Kawasumi Laboratories, Inc. is 120 days. Since 2017: 120 days, versus 177 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Sb-Kawasumi Laboratories, Inc.?
The most frequent FDA product codes under this applicant name are JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection, 3); KNS (Unit, Electrosurgical, Endoscopic (With Or Without Accessories), 1); PTI (Non-Coring (Huber) Needle, 1).
Next steps
- See all 5 Sb-Kawasumi Laboratories, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JKA, Sb-Kawasumi Laboratories, 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.