ProSeal In Line Pump Set (423850)
by Epic Medical Pte., Ltd. 510(k)
Active
510(k) K241735
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK241735 | Date10 Oct 2024 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 25 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- ONB
- FDA applicant
- Epic Medical Pte. , Ltd.
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.5440
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 20 Sep 2026
The ProSeal In Line Pump Set (423850) is a Closed Antineoplastic and Hazardous Drug Reconstitution and Transfer System, designed to facilitate the safe transfer and administration of hazardous drugs or infusates. It provides a closed-system connection between a standard IV set and a ProSeal Injection Site, minimizing exposure risk during drug handling and infusion processes. This system is engineered to maintain containment and reduce contamination risks associated with hazardous substances.
This device is intended for single-use in clinical settings, including general hospital environments, and is supplied sterile for immediate use. It is classified as a Class II medical device under FDA regulations and has received FDA 510(k) clearance as a substantially equivalent device. The set is compatible with standard IV administration protocols and must be used in conjunction with a ProSeal Injection Site (K240433) for proper functionality. Storage and handling should adhere to sterile medical device protocols to ensure integrity and safety.
Other devices from Epic Medical Pte., Ltd.
Questions
AI-generated answers, 20 Sep 2026
What is the primary purpose of the ProSeal In Line Pump Set (423850) in clinical settings?
The ProSeal In Line Pump Set (423850) is designed as a Closed Antineoplastic and Hazardous Drug Reconstitution and Transfer System to safely transfer and administer hazardous drugs or infusates. It creates a sealed connection between a standard IV set and a ProSeal Injection Site, reducing exposure risk to healthcare workers and minimizing contamination during drug handling and infusion.
Is the ProSeal In Line Pump Set meant for single-use or repeated use in a hospital?
This device is explicitly intended for single-use only in clinical settings, including general hospitals. It is supplied sterile and must not be reused to maintain safety and compliance with sterile medical device protocols.
How should the ProSeal In Line Pump Set be stored to ensure its integrity?
The ProSeal In Line Pump Set should be stored following standard sterile medical device protocols to preserve its integrity. Since it is supplied sterile for immediate use, it must remain unopened and protected from contamination until deployment in a clinical setting.
What other component is required for the ProSeal In Line Pump Set to function properly?
The ProSeal In Line Pump Set (423850) must be used in conjunction with a ProSeal Injection Site (identified by its own product code, K240433) to ensure proper functionality and maintain the closed-system design for safe drug transfer.
What regulatory pathway was followed for FDA clearance of this device?
The ProSeal In Line Pump Set received FDA 510(k) clearance under a Special Review classification, with a decision code of *SESE* (Substantially Equivalent, Special). It was filed as a Class II medical device and is intended for use in general hospital environments, as indicated by its advisory committee designation.