510(k) K212262
- Device
- PCA Syringe Sets
- Applicant
- Baxter Healthcare Corporation
- 510(k) number
- K212262
- Product code
- FPA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-10-03
- Date received
- 2021-07-20
- 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
- N
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- Jeffrey E. Thompson
- Address
- 25212 W. Illinois Rte. 120 Round Lake IL US 60073 60073
FDA Registration Numbers
- 1450662
- 3013820501
- 3003700453
- 1416980
- 3000240707
- 3008307705
- 1450392
- 3015453963
- 1037885
- 3013188547
- 1063382
- 3009742443
- 1035907
- 3006260740
- 3014162214
- 3007007790
- 3012809732
- 3015142721
- 2032521
- 3012429465
- 2649614
- 3006194679
- 3030447506
- 9616099
- 3014314985
- 1319660
- 1423537
- 3007363456
- 3003704957
- 3033589330
- 3006950086
- 3004143450
- 3024122953
- 3003678543
- 3000247873
- 3017210488
- 3014662855
- 3002807314
- 3003915875
- 3012337868
- 3007305485
- 3030733800
- 9616067
- 3033536319
- 3006174295
- 8020040
- 9612152
- 3004140833
- 3006942524
- 3015620563
- 3005669815
- 3013319212
- 3042955949
- 3029973819
- 3009631669
- 9610993
- 3015173212
- 1526611
- 3017509841
- 3013445787
- 3015537049
- 3014579161
- 1933913
- 3008448733
- 3010966701
- 3003310007
- 3016727301
- 9610825
- 3003895440
- 3007616112
- 3009515470
- 3010047442
- 3010432890
- 2032112
- 3016761372
- 3004605321
- 3003627840
- 3012104670
- 2030598
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
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 |