Cleared Traditional

K130097 - MEDMATE TRANSFER ADAPTER AM5500 & AM5500-NS

K130097 is an FDA 510(k) clearance for MEDMATE TRANSFER ADAPTER AM5500 & AM5500-NS, manufactured by American Medical Manufacturing, Inc./ Advanced Med. The device is a Class 2 General Hospital device with product code FMI cleared through the Traditional 510(k) pathway after a 553-day FDA review.

K130097 · American Medical Manufacturing, Inc./ Advanced Med · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2014
Decision
553d
Days
Class 2
Risk

K130097 is an FDA 510(k) clearance for the MEDMATE TRANSFER ADAPTER AM5500 & AM5500-NS. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by American Medical Manufacturing, Inc./ Advanced Med (Northridge, US). The FDA issued a Cleared decision on July 22, 2014 after a review of 553 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

FDA 510(k) Submission Details - K130097

510(k) Number K130097 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 15, 2013
Decision Date July 22, 2014
Days to Decision 553 days
Submission Type Traditional
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
424d slower than avg
Panel avg: 129d · This submission: 553d
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 599
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