510(k) K011187
- Device
- SIMPLICITY SOFT YP INFUSION SET FOR USE WITH THE MINIMED PARAGIGM INFUSION PUMPS
- Applicant
- STERLING MEDIVATIONS, INC.
- 510(k) number
- K011187
- Product code
- FPA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2001-06-19
- Date received
- 2001-04-18
- Regulation
- 880.5440
- Classification name
- Set, Administration, Intravascular
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Abbreviated
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- JOEL DOUGLAS
- Address
- 180 Ferndale Rd. S. Wayzata MN US 55391 55391
FDA Registration Numbers#
- 1123137
- 9615817
- 1450392
- 3022699058
- 3003678543
- 3018507299
- 9611004
- 1060680
- 1000304305
- 3010041511
- 3006158088
- 3010432890
- 2321034
- 3010131137
- 9610847
- 3015173212
- 3015453963
- 2030624
- 1724474
- 3004519921
- 3033589330
- 8010026
- 9680306
- 1723241
- 1417485
- 2245270
- 2024064
- 3003512059
- 8041187
- 8021083
- 3017509841
- 9680425
- 3007392007
- 2032227
- 3007590959
- 9614279
- 9615588
- 3005669815
- 3006891665
- 2030598
- 3003442380
- 3002807090
- 3013023255
- 3007939342
- 9615908
- 9680448
- 1319211
- 3016661372
- 1820334
- 3003915875
- 3015058854
- 1720929
- 9616567
- 3005987567
- 3002806818
- 3014732157
- 3006942524
- 1713468
- 3004906872
- 3005012805
- 3006846316
- 9612051
- 3014162214
- 1526611
- 3011642792
- 1000587249
- 3013557562
- 3011689956
- 3042955949
- 9610993
- 1416980
- 3016727301
- 3007829657
- 8041145
- 3009746061
- 1417592
- 3013055489
- 3009882464
- 9681835
Source Documents#
Other 510(k) Records For Product Code FPA #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K234129 | Ecomed Disposable Administration Sets | Ecomed Solutions, LLC | 2024-09-20 |
Legacy Summary#
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
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