Cleared Traditional

K925869 - SHEATHES, STERILE SHEATHES

K925869 is an FDA 510(k) clearance for SHEATHES, manufactured by Mayer Laboratories. The device is a Class 2 Radiology device with product code ITX cleared through the Traditional 510(k) pathway after a 413-day FDA review.

K925869 · Mayer Laboratories · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1994
Decision
413d
Days
Class 2
Risk

K925869 is an FDA 510(k) clearance for the SHEATHES, STERILE SHEATHES. Classified as Transducer, Ultrasonic, Diagnostic (product code ITX), Class II - Special Controls.

Submitted by Mayer Laboratories (Oakland, US). The FDA issued a Cleared decision on January 6, 1994 after a review of 413 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1570 - the FDA radiology and imaging software 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: 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 Radiology submissions.

View all Mayer Laboratories devices

FDA 510(k) Submission Details - K925869

510(k) Number K925869 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 1992
Decision Date January 06, 1994
Days to Decision 413 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
306d slower than avg
Panel avg: 107d · This submission: 413d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ITX Device Classification - Class 2, Special Controls

Product Code ITX Transducer, Ultrasonic, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1570
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 Radiology devices follow this clearance model.

Regulatory Peers - ITX Transducer, Ultrasonic, Diagnostic

All 259
Devices cleared under the same product code (ITX) and FDA review panel - the closest regulatory comparables to K925869.
INTERSPEC APOGEE RX400 ULTRASOUND IMAGING SYSTEM AND DOPPLER ULTRASOUND FLOWMETER
K940671 · Interspec, Inc. · Nov 1994
SMARTNEEDLE VASCULAR ACCESS SYSTEM, MODIFICATION
K940804 · Peripheral Systems Group · Jun 1994
MODIFICATION OF ACUSON V510B TRANSDUCER
K933663 · Acuson Corp. · Jan 1994
SMARTNEEDLE(R) OVER-THE-NEEDLE CATHETER
K932777 · Peripheral Systems Group · Oct 1993
CARDIOMETRICS FLOWIRE & FLOMAP
K932536 · Cardio Metrics, Inc. · Sep 1993
ACUSON V714 TRANSDUCER
K920882 · Acuson Corp. · Mar 1993