Cleared Traditional

K864984 - ROBINJECT

K864984 is an FDA 510(k) clearance for ROBINJECT, manufactured by International Medical Products, Inc.. The device is a Class 2 General Hospital device with product code KZE cleared through the Traditional 510(k) pathway after a 189-day FDA review.

K864984 · International Medical Products, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1987
Decision
189d
Days
Class 2
Risk

K864984 is an FDA 510(k) clearance for the ROBINJECT. Classified as Injector, Fluid, Non-electrically Powered (product code KZE), Class II - Special Controls.

Submitted by International Medical Products, Inc. (Minneapolis, US). The FDA issued a Cleared decision on June 29, 1987 after a review of 189 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5430 - 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 International Medical Products, Inc. devices

FDA 510(k) Submission Details - K864984

510(k) Number K864984 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 1986
Decision Date June 29, 1987
Days to Decision 189 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
60d slower than avg
Panel avg: 129d · This submission: 189d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KZE Device Classification - Class 2, Special Controls

Product Code KZE Injector, Fluid, Non-electrically Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5430
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.