Injection Site
FDA 510(k) K932446 · 3M Health Care, Ltd.
510(k) numberK932446
Submission
- Device name
- Injection Site
- Applicant
- 3M Health Care, Ltd.
St. Paul, MN, US - Received
- May 20, 1993
- Decision date
- November 29, 1993
- 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
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|---|---|---|---|
| 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 |
|---|---|---|
| K953904 | Sarns 9000 Universal Roller PumpDWB · Traditional | 04/19/1996SE |
| K926364 | Attest Brand Rapid Readout Biological Ind. #129XFRC · Traditional | 03/31/1995SE |
| K941534 | Modular VS-22 Cemented Femoral Hip SystemKWY · Traditional | 03/06/1995SE |
| K941748 | Steri-Vac Gas Sterilizer Model 8XLFLF · Traditional | 12/02/1994SE |
| K930681 | 3M Prevention Fabric Surgical Gown #78XXFYA · Traditional | 02/10/1994SE |
| K932307 | 3M Maxi-Driver II Dbattery Powered SystemKIJ · Traditional | 01/07/1994SE |
| K932422 | 3M Tegaderm HP Transparent DressingKGX · Traditional | 12/27/1993SE |
| K931968 | Cdi 100 Extracorporeal Hematocrit/Oxygen SaturatioDRY · Traditional | 11/10/1993SE |
| K933006 | Avi Infusion Pumps, Additional Intended UseFRN · Traditional | 10/25/1993SE |
| K933005 | Avi Model 600 Syringe PumpFRN · Traditional | 10/25/1993SE |
Questions and answers
When was Injection Site cleared by the FDA?
Injection Site (K932446) received a 510(k) decision of Substantially Equivalent on November 29, 1993, 193 days after the submission was received.
What is the product code of K932446?
The FDA product code is FPA – Set, Administration, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 880.5440.