Cleared Traditional

K945431 - MODEL 792 CONVERGE, MODEL 793 VISION 2000

K945431 is an FDA 510(k) clearance for MODEL 792 CONVERGE, manufactured by Hausted, Inc.. The device is a Class 2 General Hospital device with product code FPO cleared through the Traditional 510(k) pathway after a 163-day FDA review.

K945431 · Hausted, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1995
Decision
163d
Days
Class 2
Risk

K945431 is an FDA 510(k) clearance for the MODEL 792 CONVERGE, MODEL 793 VISION 2000. Classified as Stretcher, Wheeled (product code FPO), Class II - Special Controls.

Submitted by Hausted, Inc. (Medina, US). The FDA issued a Cleared decision on January 25, 1995 after a review of 163 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6910 - the FDA general hospital 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Hausted, Inc. devices

FDA 510(k) Submission Details - K945431

510(k) Number K945431 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 1994
Decision Date January 25, 1995
Days to Decision 163 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
34d slower than avg
Panel avg: 129d · This submission: 163d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FPO Device Classification - Class 2, Special Controls

Product Code FPO Stretcher, Wheeled
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6910
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 General Hospital devices follow this clearance model.

Regulatory Peers - FPO Stretcher, Wheeled

All 17
Devices cleared under the same product code (FPO) and FDA review panel - the closest regulatory comparables to K945431.
WHEELED STRETCHER
K961437 · Hill-Rom, Inc. · Jun 1996
HILL-ROM AMBULATORY CARE PROCEDURAL STRETCHER
K952447 · Hill-Rom, Inc. · Nov 1995
EMERGENCY/ACCIDENT TROLLEY 550
K946101 · Hogan & Hartson · Feb 1995
STRYKER POWERED STRETCHER
K942948 · Stryker Corp. · Jan 1995
MODEL 561 C-ARM PROCEDURES STRETCHER
K923730 · Midmark Corp. · Feb 1994
HILL-ROM VIA STRETCHER (P1300 - P1303)
K922808 · Hill-Rom, Inc. · Mar 1993