510(k) K162812
- Device
- Unomedical Comfort Subcutaneous Infusion Set, Unomedical Comfort Short Subcutaneous Infusion Set, Unomedical Neria Soft Subcutaneous Infusion Set, Medtronic Silhouette Subcutaneous Infusion Set, Medtronic Silhouette Paradigm Subcutaneous Infusion Set
- Applicant
- UNOMEDICAL A/S
- 510(k) number
- K162812
- Product code
- FPA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2017-11-01
- Date received
- 2016-10-06
- 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
- John M. Lindskog
- Address
- Aaholmvej 1-3 Osted DK DK-4000 DK-4000
FDA Registration Numbers#
- 1450392
- 3007185216
- 3008717264
- 9610825
- 3032916632
- 3011088743
- 9617475
- 3003700453
- 3018507299
- 1000595987
- 3030626857
- 3016472589
- 3010293992
- 3008537309
- 3024122953
- 3010419931
- 3015085713
- 3015997711
- 3009746425
- 1217831
- 3010621964
- 3007305485
- 3014456066
- 1123137
- 3012410077
- 3014579161
- 3005405146
- 2025816
- 3015537049
- 9681572
- 9680425
- 2032227
- 3011944170
- 3004416208
- 3009328501
- 3007817041
- 3044994889
- 2521402
- 3017509841
- 3035111606
- 3010082909
- 1060680
- 1721504
- 3011237770
- 3010162782
- 8020785
- 3043226252
- 3009742443
- 1125615
- 3010047442
- 1018233
- 3016727301
- 3015192982
- 3010432890
- 3005934752
- 3003310007
- 3008448733
- 3011689956
- 3002907620
- 3017406698
- 1721686
- 1000304305
- 3013820501
- 1055236
- 1019003
- 3009518015
- 9611004
- 9617604
- 3017636737
- 3007363456
- 1220905
- 1319660
- 1024879
- 9615588
- 3012494290
- 3006795797
- 3036978618
- 2523676
- 3002807350
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#
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