Cleared Special

K243354 - Remunity System (FDA 510(k) Clearance)

Class II General Hospital device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K243354 · Deka Research & Development Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2024
Decision
29d
Days
Class 2
Risk

K243354 is an FDA 510(k) clearance for the Remunity System. Classified as Infusion Pump, Drug Specific, Pharmacy-filled (product code QJY), Class II - Special Controls.

Submitted by Deka Research & Development Corp. (Manchester, US). The FDA issued a Cleared decision on November 27, 2024 after a review of 29 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5725 - the FDA general hospital device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Deka Research & Development Corp. devices

Submission Details

510(k) Number K243354 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 29, 2024
Decision Date November 27, 2024
Days to Decision 29 days
Submission Type Special
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
99d faster than avg
Panel avg: 128d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code QJY Infusion Pump, Drug Specific, Pharmacy-filled
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5725
Definition A Pharmacy-filled, Drug Specific Infusion System Is A Prescription Device Intended For Delivery Of A Specific Drug In Accordance With The Fda Approved Labeling And May Be Filled At A Location Other Than Point Of Care.
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.