510(k) K192681
- Device
- Safety scalp vein set, Scalp vein set, Blood collection needle (Scalp vein set type), Blood collection needle (Needle holder type), Safety blood collection needle (Scalp vein set type), Safety blood collection needle (Needle holder type)
- Applicant
- Jiangsu Kangbao Medical Equipment Co., Ltd.
- 510(k) number
- K192681
- Product code
- FPA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2020-07-28
- Date received
- 2019-09-26
- Regulation
- 880.5440
- Classification name
- Set, Administration, Intravascular
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Rujun Tang
- Address
- 78#, N. Suzhong Rd. Baoying Yangzhou CN 225800 225800
FDA Registration Numbers#
- 1123137
- 9615817
- 1450392
- 3022699058
- 3003678543
- 3018507299
- 9611004
- 1060680
- 1000304305
- 3010041511
- 3006158088
- 3010432890
- 2321034
- 3010131137
- 9610847
- 3015173212
- 3015453963
- 2030624
- 1724474
- 3004519921
- 3033589330
- 8010026
- 9680306
- 1723241
- 1417485
- 2245270
- 2024064
- 3003512059
- 8041187
- 8021083
- 3017509841
- 9680425
- 3007392007
- 2032227
- 3007590959
- 9614279
- 9615588
- 3005669815
- 3006891665
- 2030598
- 3003442380
- 3002807090
- 3013023255
- 3007939342
- 9615908
- 9680448
- 1319211
- 3016661372
- 1820334
- 3003915875
- 3015058854
- 1720929
- 9616567
- 3005987567
- 3002806818
- 3014732157
- 3006942524
- 1713468
- 3004906872
- 3005012805
- 3006846316
- 9612051
- 3014162214
- 1526611
- 3011642792
- 1000587249
- 3013557562
- 3011689956
- 3042955949
- 9610993
- 1416980
- 3016727301
- 3007829657
- 8041145
- 3009746061
- 1417592
- 3013055489
- 3009882464
- 9681835
Source Documents#
Other 510(k) Records For Product Code FPA#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K242339 | Intravascular Extension Sets and Accessories | Baxter Healthcare Corporation | 2025-02-28 |
| K241058 | Lyka® PORT Needle Free Access Device (4170Y) | Quest Medical, Inc. | 2024-12-18 |
| K234129 | Ecomed Disposable Administration Sets | Ecomed Solutions, LLC | 2024-09-20 |