Identifiers
- 510(k) Number
- K932637 FDA 510(k)
- FDA Product Code
- FPA FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.5440 FDA 510(k)
- Regulation Number
- 880.5440 FDA 510(k)
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
A subcutaneous infusion set is a device designed for the insertion of medications beneath the skin either by injection or infusion. It is used to deliver fluids or drugs into the subcutaneous tissue layer.
This device is supplied as a sterile, single-use infusion set intended for use in general hospital settings. It received FDA 510(k) clearance under K932637 with product code FPA and is classified as substantially equivalent to a legally marketed device.
Frequently asked questions
What is the subcutaneous infusion set used for?
The subcutaneous infusion set is designed for the insertion of medications beneath the skin either by injection or infusion to deliver fluids or drugs into the subcutaneous tissue layer, intended for use in general hospital settings.
Is the subcutaneous infusion set sterile and single-use?
Yes, the device is supplied as a sterile, single-use infusion set, meaning it is intended for one-time use only and must be discarded after each procedure to maintain sterility and prevent cross-contamination.
Who manufactures the subcutaneous infusion set and what is its FDA authorization?
The subcutaneous infusion set is manufactured by Douglas Medical Products Corp. and received FDA 510(k) clearance under K932637, with product code FPA, as a substantially equivalent device to a legally marketed predicate.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Subcutaneous administration - Wikipedia
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K932637 | Class II | Active |
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Manufacturer
- Manufacturer
- Douglas Medical Products Corp.
Sources (1)
- FDA 510(k) K932637 24 fields · synced Sep 23, 2026