Filtered Extension Sets
FDA 510(k) K942988 · B. Braun of America, Inc.
510(k) numberK942988
Submission
- Device name
- Filtered Extension Sets
- Applicant
- B. Braun of America, Inc.
Bethlehem, PA, US - Received
- June 20, 1994
- Decision date
- July 14, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FPA – Set, Administration, Intravascular
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5440
- Specialty
- General Hospital
Other 510(k)s with product code FPA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254123 | Ecomed Disposable Administration SetsFPA · Abbreviated | Ecomed Solutions, LLC | 09/11/2026SE |
| K261530 | iiSure Infusion SetFPA · Special | Deka Research and Development | 06/03/2026SE |
| K252543 | AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072…FPA · Traditional | Amsino International, Inc. | 05/04/2026SE |
| K251375 | PuraCath Firefly Needleless Connector IT (9005)FPA · Traditional | Puracath Medical, Inc. | 02/12/2026SE |
| K251257 | nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Free…FPA · Traditional | Np Medical | 12/04/2025SE |
| K250325 | BD Alaris Pump Infusion SetFPA · Traditional | Carefusion (Bd) | 10/30/2025SE |
| K251814 | EZ IV Administration SetFPA · Traditional | Epic Medical Pte. , Ltd. | 08/29/2025SE |
| K251854 | SteadiSet infusion setFPA · Abbreviated | Tandem Diabetes Care | 08/06/2025SE |
| K243841 | Sparta Infusion Set for InsulinFPA · Traditional | Deka Research and Development | 08/01/2025SE |
| K243392 | Infusomat® Space Volumetric Infusion Pump Administration SetsFPA · Traditional | B.Braun Medical, Inc. | 07/24/2025SE |
More from B.Braun Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K993024 | Celsite Implantable Port with Valved CatheterLJT · Traditional | 03/13/2000SE |
| K983794 | Chemo Mini Spike PlusLHI · Traditional | 03/23/1999SE |
| K946170 | Comfort-Q Subcutaneous Injection SetsFOZ · Traditional | 11/03/1995SE |
| K945850 | Braun Diacan(R) Fistula NeedlesFIE · Traditional | 10/06/1995SE |
| K945752 | Celsite(Tm) Brachial Venous PortLJT · Traditional | 05/31/1995SE |
| K945551 | Celsite(Tm) Dual Venous SystemLJT · Traditional | 04/21/1995SE |
| K943770 | Low Volume MultiportFPA · Traditional | 04/10/1995SE |
| K950982 | B. Braun Sonocan Biopsy Needle and Aspiration HandleFCG · Traditional | 04/04/1995SE |
| K950184 | B. Braun IV Start KitsLRS · Traditional | 03/15/1995SEKD |
| K943181 | Dispensing Pin with One-Way ValveLHI · Traditional | 09/29/1994SE |
Questions and answers
When was Filtered Extension Sets cleared by the FDA?
Filtered Extension Sets (K942988) received a 510(k) decision of Substantially Equivalent on July 14, 1995, 389 days after the submission was received.
What is the product code of K942988?
The FDA product code is FPA – Set, Administration, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 880.5440.