Cleared Traditional

K992729 - NIPRO LUER ADAPTOR

K992729 is the FDA 510(k) clearance for NIPRO LUER ADAPTOR by Nipro Medical Corp.. It is a Class 2 General Hospital device (product code FMI) cleared through the Traditional 510(k) pathway after a 153-day FDA review.

K992729 · Nipro Medical Corp. · General Hospital
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Jan 2000
Decision
153d
Days
Class 2
Risk

K992729 is an FDA 510(k) clearance for the NIPRO LUER ADAPTOR. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Nipro Medical Corp. (Lexington, US). The FDA issued a Cleared decision on January 13, 2000 after a review of 153 days - an extended review cycle.

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 Nipro Medical Corp. devices

Submission Details

510(k) Number K992729 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 1999
Decision Date January 13, 2000
Days to Decision 153 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
24d slower than avg
Panel avg: 129d · This submission: 153d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 260
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K992729.
BODYGUARD
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DEROYAL INDUSTRIES, INC TRACECART SHARPS COLLECTION CONTAINER
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K971924 · B.Braun Medical, Inc. · Sep 1998