510(k) K781744
- Device
- IV SET WITH GRADUATED CHAMBER
- Applicant
- NATIONAL PATENT DEVELOPMENT CORP.
- 510(k) number
- K781744
- Product code
- FPA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1978-12-07
- Date received
- 1978-10-20
- Regulation
- 880.5440
- Classification name
- Set, Administration, Intravascular
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3004911384
- 2320762
- 3015859709
- 3011088743
- 3012187635
- 1000563940
- 3006425876
- 3006942602
- 3018125942
- 3012116434
- 3003915875
- 1223004
- 3014662855
- 3006194679
- 3015537049
- 3014456066
- 3030989877
- 9612057
- 2523167
- 9610847
- 3003674698
- 9616088
- 3006271008
- 9681835
- 3000240707
- 3003895440
- 1019003
- 3030626857
- 3004416208
- 3031233007
- 1649518
- 3033589330
- 3045816907
- 9615050
- 3003310007
- 3015142721
- 2025816
- 3000247873
- 2032098
- 9680222
- 3010621964
- 1055927
- 2243072
- 2427500
- 3033536319
- 3007007790
- 9610825
- 3006846316
- 1030451
- 9612052
- 1932668
- 3016938816
- 3012429465
- 2183650
- 2032227
- 3010047442
- 3013557562
- 3017262697
- 3002808466
- 2648727
- 9617229
- 9617475
- 3018507299
- 3010293992
- 3012039263
- 1123137
- 1220973
- 1037885
- 8021079
- 3008782867
- 3020777588
- 3006479639
- 3042871620
- 9680794
- 2032112
- 3015453963
- 3036978618
- 1720734
- 3002807350
Source Documents#
510(k) summary PDF not indicated by FDA
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#
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FDA Review#
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