Cleared Traditional

K050557 - AMT NANOCATH

K050557 is an FDA 510(k) clearance for AMT NANOCATH, manufactured by American Medical Technologies, Inc.. The device is a Class 2 Anesthesiology device with product code BSO cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K050557 · American Medical Technologies, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2005
Decision
85d
Days
Class 2
Risk

K050557 is an FDA 510(k) clearance for the AMT NANOCATH. Classified as Catheter, Conduction, Anesthetic (product code BSO), Class II - Special Controls.

Submitted by American Medical Technologies, Inc. (Riviera Beach, US). The FDA issued a Cleared decision on May 27, 2005 after a review of 85 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5120 - the FDA anesthesiology and respiratory 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all American Medical Technologies, Inc. devices

FDA 510(k) Submission Details - K050557

510(k) Number K050557 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 2005
Decision Date May 27, 2005
Days to Decision 85 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
55d faster than avg
Panel avg: 140d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BSO Device Classification - Class 2, Special Controls

Product Code BSO Catheter, Conduction, Anesthetic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5120
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 Anesthesiology devices follow this clearance model.

Regulatory Peers - BSO Catheter, Conduction, Anesthetic

All 55
Devices cleared under the same product code (BSO) and FDA review panel - the closest regulatory comparables to K050557.
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PERIFIX CATHETER AND CONTIPLEX CATHETER
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MODIFICATION TO EBI TARGETCATH FLUORO-GUIDED STEERABLE CATHETER SYSTEM
K032390 · Ebi, L.P. · Aug 2003