510(k) K190233
- Device
- K-Shield Advantage Port Access Infusion Set (PAIS)
- Applicant
- Kawasumi Laboratories, Inc.
- 510(k) number
- K190233
- Product code
- FPA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2019-05-02
- Date received
- 2019-02-06
- Regulation
- 880.5440
- Classification name
- Set, Administration, Intravascular
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Katsu Furuya
- Address
- Shinagawa Intercity Tower B, 9th Floor 2-15-2, Konan, Minato-Ku Tokyo JP 108-6109 108-6109
FDA Registration Numbers#
- 3003700453
- 8021545
- 3009456923
- 1000523114
- 3002806603
- 2029015
- 3016472589
- 3012302888
- 3011944170
- 9617592
- 9611590
- 3006425876
- 1314417
- 3013696225
- 3004111573
- 3043226252
- 3033589330
- 3003974574
- 9681835
- 1000587249
- 3044994889
- 3044026004
- 1833470
- 2437459
- 2523676
- 9610825
- 1410248
- 3012116434
- 3015060216
- 3005515211
- 8020040
- 2025816
- 3012187973
- 9680425
- 3010413216
- 3003895440
- 3003442380
- 3007363456
- 3014162214
- 3009976527
- 3014732157
- 9615050
- 3010082909
- 3013023255
- 1035907
- 3008537309
- 3009746061
- 3018071447
- 1713468
- 3007817041
- 3015309643
- 3003310007
- 2321034
- 2030624
- 3020417125
- 3043051314
- 3006542380
- 1037885
- 3017262697
- 1043214
- 3015620563
- 9617229
- 1024879
- 3015276780
- 1722139
- 2032112
- 3024122953
- 2427500
- 3035642068
- 1063382
- 1047843
- 1016427
- 1000112137
- 1644312
- 2245270
- 3004102031
- 1423537
- 3010047442
- 3030989877
Source Documents#
Other 510(k) Records For Product Code FPA #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260261 | Gravity Blood Sets with 200µm Filter | B.Braun Medical, Inc. | 2026-10-22 |
| K254123 | Ecomed Disposable Administration Sets | Ecomed Solutions, LLC | 2026-09-11 |
| K261530 | iiSure Infusion Set | Deka Research and Development | 2026-06-03 |
| 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) | Amsino International, Inc. | 2026-05-04 |
| K251375 | PuraCath Firefly Needleless Connector IT (9005) | Puracath Medical, Inc. | 2026-02-12 |
| K251257 | nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Free Connector (NFC) [6426731]; nSyte Needle Free Connector (NFC) [6426727] | Np Medical | 2025-12-04 |
| K250325 | BD Alaris Pump Infusion Set | Carefusion (Bd) | 2025-10-30 |
| K251814 | EZ™ IV Administration Set | Epic Medical Pte. , Ltd. | 2025-08-29 |
| K251854 | SteadiSet infusion set | Tandem Diabetes Care | 2025-08-06 |
| K243841 | Sparta Infusion Set for Insulin | Deka Research and Development | 2025-08-01 |
| K243392 | Infusomat® Space Volumetric Infusion Pump Administration Sets | B.Braun Medical, Inc. | 2025-07-24 |
| K250616 | Clave™ Neutral-Displacement Needlefree Connectors | Icu Medical, Inc. | 2025-06-05 |
| K242692 | SteadiSet Infusion Set | Capillary Biomedical, LLC | 2025-05-09 |
| K242763 | JetCan® Pro Safety Huber Needle | Pfm Medical, Inc. | 2025-05-02 |
| K243529 | Solution Administration Sets | Baxter Healthcare Corporation | 2025-03-14 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases