Cleared Traditional

K941801 - ANALGRAPH

K941801 is an FDA 510(k) clearance for ANALGRAPH, manufactured by Sandhill Scientific, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KLA cleared through the Traditional 510(k) pathway after a 514-day FDA review.

K941801 · Sandhill Scientific, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1995
Decision
514d
Days
Class 2
Risk

K941801 is an FDA 510(k) clearance for the ANALGRAPH. Classified as Monitor, Esophageal Motility, Anorectal Motility, And Tube (product code KLA), Class II - Special Controls.

Submitted by Sandhill Scientific, Inc. (Littleton, US). The FDA issued a Cleared decision on September 8, 1995 after a review of 514 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1725 - the FDA gastroenterology and urology 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: 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 Gastroenterology & Urology submissions.

View all Sandhill Scientific, Inc. devices

FDA 510(k) Submission Details - K941801

510(k) Number K941801 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 12, 1994
Decision Date September 08, 1995
Days to Decision 514 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
383d slower than avg
Panel avg: 131d · This submission: 514d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KLA Device Classification - Class 2, Special Controls

Product Code KLA Monitor, Esophageal Motility, Anorectal Motility, And Tube
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1725
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 Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - KLA Monitor, Esophageal Motility, Anorectal Motility, And Tube

All 19
Devices cleared under the same product code (KLA) and FDA review panel - the closest regulatory comparables to K941801.
ESOPHAGEAL MANOMETRY ANALYSIS MODULE
K961070 · Synectics Medical, Inc. · Jun 1996
BIOVIEW MODEL S960000
K961056 · Sandhill Scientific, Inc. · Jun 1996
7100 SWALLOWING WORKSTATION
K954798 · Kay Elemetrics Corp. · Jun 1996
MONOCRYSTANT PH/LES CATHETER, MODIFICATION
K914793 · Synectics-Dantec · Dec 1993
PROVOCATIVE SENSITIVITY BALLOON
K901125 · Wilson-Cook Medical, Inc. · Jan 1991
WILSON-COOK ESOPHAGEAL MOTILITY CATHETER
K900239 · Wilson-Cook Medical, Inc. · Jul 1990