510(k) K142367
- Device
- Hospira Primary Sets
- Applicant
- HOSPIRA, INC.
- 510(k) number
- K142367
- Product code
- FPA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2014-11-25
- Date received
- 2014-08-25
- 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
- CATHERINE KANG
- Address
- 375 N. Field Dr. Lake Forest IL US 60045 60045
FDA Registration Numbers#
- 3004416208
- 2523676
- 3007344957
- 1422634
- 1833470
- 3010621964
- 3006271008
- 3016661372
- 3034669683
- 3000240707
- 3038356900
- 1423662
- 1035907
- 1710034
- 3004102031
- 3003512059
- 3018229072
- 1000112137
- 2032227
- 1820334
- 1220973
- 2244478
- 3017961114
- 3010419931
- 8020040
- 3012050423
- 3016904853
- 3003700453
- 9617475
- 3012039263
- 2437459
- 8041187
- 3019004087
- 3008328679
- 3031233007
- 1054241
- 1713468
- 3029973819
- 1647137
- 3012445205
- 3003915875
- 1018470
- 1018233
- 3045322464
- 3006575795
- 9612152
- 3010293992
- 3011987967
- 8021083
- 1644312
- 8010026
- 3002807090
- 3010882065
- 3009518015
- 3014936217
- 3010041511
- 2025816
- 3019807891
- 2649614
- 3010291427
- 1047429
- 2520313
- 1224960
- 3012421607
- 3010413216
- 3008132411
- 3016798778
- 3013023255
- 3002806818
- 2248588
- 3014246639
- 3015276780
- 2030624
- 3018125942
- 3002296055
- 3029706818
- 1024879
- 3015085713
- 3007817041
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 |
| 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 |
Legacy Summary#
summary
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