510(k) K001233
- Device
- ACTI-FLEX FLUID DELIVERY SYSTEM OR ACTI-FLEX F D S
- Applicant
- R-GROUP INTL.
- 510(k) number
- K001233
- Product code
- FPA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2000-12-13
- Date received
- 2000-04-17
- 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
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- KERRY ANNE KAHN
- Address
- 2321 NW 66th Ct., Suite W-4 Gainesville FL US 32653 32653
FDA Registration Numbers#
- 9611590
- 1063851
- 1048735
- 1047843
- 3014162214
- 3013298431
- 1721504
- 3009656988
- 3003915875
- 3044026004
- 3004102031
- 3009746061
- 1625425
- 1319639
- 3007616112
- 3013187142
- 3030419987
- 3006891665
- 1063382
- 3015620563
- 3009518015
- 3006194679
- 3012445205
- 3010293992
- 3015142721
- 3017088037
- 9615817
- 3003189845
- 3035111606
- 3024122953
- 3010531069
- 1526611
- 1125615
- 9617604
- 3004215921
- 1223004
- 9681819
- 3015537049
- 3004569180
- 1643817
- 3007344957
- 2011068
- 3016798778
- 3009976527
- 3012104670
- 1644312
- 3015724078
- 3010872792
- 3012410077
- 1224960
- 2649614
- 3012461127
- 3010381606
- 2025816
- 1911916
- 3007738736
- 9615588
- 2248588
- 1820334
- 3013319212
- 3013234390
- 3015983454
- 3013055489
- 1928237
- 3010131137
- 3010419931
- 9680222
- 1000112137
- 3013445787
- 3013696225
- 9617475
- 3010621964
- 1720929
- 3005941719
- 1419937
- 3008328679
- 9617594
- 8020785
- 3006479639
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#
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