Cleared Traditional

K936235 - NEEDLESAFE II & NEEDLEGARD II

K936235 is an FDA 510(k) clearance for NEEDLESAFE II & NEEDLEGARD II, manufactured by Ingenious Technologies Corp.. The device is a Class 2 General Hospital device with product code FMI cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K936235 · Ingenious Technologies Corp. · General Hospital
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Mar 1994
Decision
94d
Days
Class 2
Risk

K936235 is an FDA 510(k) clearance for the NEEDLESAFE II & NEEDLEGARD II. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Ingenious Technologies Corp. (Massillon, US). The FDA issued a Cleared decision on March 28, 1994 after a review of 94 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5570 - 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 Ingenious Technologies Corp. devices

FDA 510(k) Submission Details - K936235

510(k) Number K936235 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 24, 1993
Decision Date March 28, 1994
Days to Decision 94 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 129d · This submission: 94d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FMI Device Classification - Class 2, Special Controls

Product Code FMI Needle, Hypodermic, Single Lumen
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5570
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 - FMI Needle, Hypodermic, Single Lumen

All 509
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