Cleared Traditional

K832847 - MEDI-JECT

K832847 is an FDA 510(k) clearance for MEDI-JECT, manufactured by Jack H. Ritterskamp. The device is a Class 2 General Hospital device with product code KZH cleared through the Traditional 510(k) pathway after a 190-day FDA review.

K832847 · Jack H. Ritterskamp · General Hospital
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Feb 1984
Decision
190d
Days
Class 2
Risk

K832847 is an FDA 510(k) clearance for the MEDI-JECT. Classified as Introducer, Syringe Needle (product code KZH), Class II - Special Controls.

Submitted by Jack H. Ritterskamp (Mchenry, US). The FDA issued a Cleared decision on February 28, 1984 after a review of 190 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6920 - 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 Jack H. Ritterskamp devices

FDA 510(k) Submission Details - K832847

510(k) Number K832847 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 22, 1983
Decision Date February 28, 1984
Days to Decision 190 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
61d slower than avg
Panel avg: 129d · This submission: 190d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KZH Device Classification - Class 2, Special Controls

Product Code KZH Introducer, Syringe Needle
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6920
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.