Cleared Traditional

K920251 - USCI HEMAQUET XT INTRODUCER

K920251 is an FDA 510(k) clearance for USCI HEMAQUET XT INTRODUCER, manufactured by C.R. Bard, Inc.. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K920251 · C.R. Bard, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1992
Decision
57d
Days
Class 2
Risk

K920251 is an FDA 510(k) clearance for the USCI HEMAQUET XT INTRODUCER. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Billerica, US). The FDA issued a Cleared decision on March 18, 1992 after a review of 57 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1340 - the FDA cardiovascular device oversight 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 C.R. Bard, Inc. devices

FDA 510(k) Submission Details - K920251

510(k) Number K920251 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 1992
Decision Date March 18, 1992
Days to Decision 57 days
Submission Type Traditional
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
68d faster than avg
Panel avg: 125d · This submission: 57d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DYB Device Classification - Class 2, Special Controls

Product Code DYB Introducer, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1340
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 - DYB Introducer, Catheter

All 598
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K920251.
FAST-CATH HEMOSTASIS INTRODUCER
K920779 · Daig Corp. · Jun 1992
GORE TUNNELER, MODIFICATION
K920998 · W.L. Gore & Associates, Inc. · Jun 1992
DAIG FAST CATH TRANSSEPTAL SHEATH INTRODUCER
K920327 · Daig Corp. · Apr 1992
GUIDEWIRE INTRODUCER SET
K915421 · B. Braun of America, Inc. · Feb 1992
USCI(R) HEMAFLEX(TM) INTRODUCER WITH COATING
K915553 · C.R. Bard, Inc. · Feb 1992
GESCO PER-Q-CATH CATHETER INTRODUCER
K915167 · Gesco Intl., Inc. · Jan 1992