Cleared Special

K072745 - Y-GLIDE

K072745 is an FDA 510(k) clearance for Y-GLIDE, manufactured by Thomas Medical Products, Inc.. The device is a Class 2 Cardiovascular device with product code DTL cleared through the Special 510(k) pathway after a 99-day FDA review.

K072745 · Thomas Medical Products, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2008
Decision
99d
Days
Class 2
Risk

K072745 is an FDA 510(k) clearance for the Y-GLIDE. Classified as Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass (product code DTL), Class II - Special Controls.

Submitted by Thomas Medical Products, Inc. (Malvern, US). The FDA issued a Cleared decision on January 4, 2008 after a review of 99 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4290 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K072745

510(k) Number K072745 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2007
Decision Date January 04, 2008
Days to Decision 99 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 125d · This submission: 99d
Pathway characteristics
Modification to existing cleared device.

DTL Device Classification - Class 2, Special Controls

Product Code DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4290
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

All 129
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K072745 · Y-GLIDE
Download PDF FDA Summary Thomas Medical Produc…