FDA 510(k) ClearanceFPA
PCA Syringe Sets
FDA 510(k) K212262 · Baxter Healthcare Corporation
- 510(k) number
- K212262
- Device name
- PCA Syringe Sets
- Applicant
- Baxter Healthcare Corporation
- Product code
- FPA
- Decision
- Substantially Equivalent
- Decision date
- Device class
- Class 2
- Regulation number
- 880.5440
- Advisory committee
- HO
- Medical specialty
- General Hospital
Candidate predicate devices
Other devices cleared under product code FPA form a screening cohort, not a predicate determination. Compare intended use, technological characteristics, performance evidence, labeling, and current legal-marketing status before selecting a predicate.
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261530 | iiSure Infusion Set | Deka Research and Development | |
| 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. | |
| K251375 | PuraCath Firefly Needleless Connector IT (9005) | Puracath Medical, Inc. | |
| K251257 | nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Free Connector (NFC) [6426731]; nSyte Needle Free Connector (NFC) [6426727] | Np Medical | |
| K250325 | BD Alaris Pump Infusion Set | Carefusion (Bd) | |
| K251814 | EZ™ IV Administration Set | Epic Medical Pte. , Ltd. | |
| K251854 | SteadiSet infusion set | Tandem Diabetes Care | |
| K243841 | Sparta Infusion Set for Insulin | Deka Research and Development | |
| K243392 | Infusomat® Space Volumetric Infusion Pump Administration Sets | B.Braun Medical, Inc. | |
| K250616 | Clave™ Neutral-Displacement Needlefree Connectors | Icu Medical, Inc. | |
| K242692 | SteadiSet Infusion Set | Capillary Biomedical, LLC | |
| K242763 | JetCan® Pro Safety Huber Needle | Pfm Medical, Inc. |
Building a 510(k) around this device type?
Assyro turns predicate research into a substantial-equivalence comparison and an eSTAR-ready 510(k) workflow — so predicate strategy, testing evidence, and labeling stay aligned before FDA review.