510(k) K250616
- Device
- Clave™ Neutral-Displacement Needlefree Connectors
- Applicant
- Icu Medical, Inc.
- 510(k) number
- K250616
- Product code
- FPA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-06-05
- Date received
- 2025-02-28
- 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
- N
Applicant Contact#
- Contact
- Nichelle Cato
- Address
- 600 N. Field Dr. Lake Forest IL US 60045 60045
FDA Registration Numbers#
- 9615817
- 3015859709
- 9610847
- 1056186
- 3004140833
- 2518902
- 2648727
- 3008810357
- 1721504
- 3017961114
- 1320894
- 3010419931
- 3006158088
- 3017088037
- 3014732157
- 3032916632
- 2433012
- 3036978618
- 3018125942
- 9616067
- 3005951712
- 1000304305
- 3014314985
- 2528981
- 3013696225
- 3014162214
- 3002806603
- 3014246639
- 3012116434
- 3002808467
- 3010515547
- 3013445787
- 1643059
- 3009976527
- 9681819
- 1043214
- 1450392
- 1220905
- 1016427
- 3012461127
- 1530671
- 3012039263
- 3005778453
- 3017406698
- 9617229
- 3017210488
- 1720929
- 3005405146
- 1000587249
- 3008733163
- 3015276780
- 3003915875
- 1423662
- 3004111573
- 3010872792
- 2024064
- 3004194523
- 9611665
- 3014312726
- 1316297
- 3005232773
- 1319660
- 3010293992
- 3003704957
- 9612057
- 1833470
- 1422078
- 3009456923
- 1055927
- 1221765
- 3014498869
- 3015060216
- 3007738736
- 2024024
- 3003189845
- 3006534321
- 3009515470
- 8020040
- 1419937
Source Documents#
Other 510(k) Records For Product Code FPA#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| 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 |