# K072745: Y-Glide

- Pathway: 510(k) (Special)
- Applicant: Thomas Medical Products, Inc.
- Decided: Jan 4, 2008 after 99 days
- Product code: DTL (Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4290
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K854261 (1985). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991102: Copilot Bleedback Control Valve, Model 1003331, Guidant Corp. (1999) Summary page 1.

## Recalls of this device
- Dec 16, 2010 · Not classified · Z-1225-2011: Compromised sterility/weak or open seals.
- Dec 16, 2010 · Not classified · Z-1228-2011: Compromised sterility/weak or open seals.

## Indications for use
The Y-GlideTM Hemostatic Wye Adapter is to be used for maintaining a hemostatic seal around inserted devices with an outside diameter up to 0.120" (3.04 mm) during the use of diagnostic/interventional devices for transluminal procedures.

Source page: https://510kreport.com/device/K072745
Methodology: https://510kreport.com/methodology