Cleared Traditional

K240433 - ProSeal Injection Site Extended Male Lu...

K240433 is the FDA 510(k) clearance for ProSeal Injection Site Extended Male Lu... by Epic Medical Pte. , Ltd.. It is a Class 2 General Hospital device (product code ONB) cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K240433 · Epic Medical Pte. , Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2024
Decision
97d
Days
Class 2
Risk

K240433 is an FDA 510(k) clearance for the ProSeal™ Injection Site Extended Male Luer Lock (422140). Classified as Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System (product code ONB), Class II - Special Controls.

Submitted by Epic Medical Pte. , Ltd. (Singapore, SG). The FDA issued a Cleared decision on May 21, 2024 after a review of 97 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5440 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Epic Medical Pte. , Ltd. devices

Submission Details

510(k) Number K240433 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 2024
Decision Date May 21, 2024
Days to Decision 97 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 129d · This submission: 97d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ONB Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5440
Definition Reconstitute And Transfer Antineoplastic And Other Hazardous Drugs In Healthcare Setting Indicated To Reduce Exposure Of Healthcare Personnel To Chemotherapy Agents In Healthcare Setting.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - ONB Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System

All 34
Devices cleared under the same product code (ONB) and FDA review panel - the closest regulatory comparables to K240433.
ProSeal™ In Line Pump Set (423850)
K241735 · Epic Medical Pte. , Ltd. · Oct 2024
ToxiSeal™ Vial Adaptor
K241823 · Epic Medical Pte. , Ltd. · Aug 2024
ToxiSeal™ Vial Adaptor with External Flip Balloon
K241476 · Epic Medical Pte. , Ltd. · Jun 2024
ProSeal™ Injector Plus (Model no. 421050)
K240171 · Epic Medical Pte. , Ltd. · Mar 2024
ToxiSeal Vial Adapter with External Balloon
K222929 · Epic Medical Pte. , Ltd. · Jan 2024
Chemfort® Catheter Adaptor
K231286 · Simplivia Healthcare , Ltd. · Aug 2023