Cleared Traditional

K926218 - EISMAN-TRIES MEP (MULTIPLE ELECTRODE PROBE)

K926218 is an FDA 510(k) clearance for EISMAN-TRIES MEP (MULTIPLE ELECTRODE PROBE), manufactured by Sandhill Scientific, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code HIR cleared through the Traditional 510(k) pathway after a 624-day FDA review.

K926218 · Sandhill Scientific, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1994
Decision
624d
Days
Class 2
Risk

K926218 is an FDA 510(k) clearance for the EISMAN-TRIES MEP (MULTIPLE ELECTRODE PROBE). Classified as Perineometer (product code HIR), Class II - Special Controls.

Submitted by Sandhill Scientific, Inc. (Littleton, US). The FDA issued a Cleared decision on August 26, 1994 after a review of 624 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 884.1425 - 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 - K926218

510(k) Number K926218 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 1992
Decision Date August 26, 1994
Days to Decision 624 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
493d slower than avg
Panel avg: 131d · This submission: 624d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HIR Device Classification - Class 2, Special Controls

Product Code HIR Perineometer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.1425
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 - HIR Perineometer

All 37
Devices cleared under the same product code (HIR) and FDA review panel - the closest regulatory comparables to K926218.
THOUGHT TECHNOLOGY VAGINAL & RECTAL ELECTRODE
K932149 · Thought Technology , Ltd. · May 1995
INCONTROL
K935213 · Thought Technology , Ltd. · May 1995
INNOVA VAGINAL EMG SENSING ELECTRODE
K940091 · Empi · Dec 1994
EXTACISER PERINEAL MUSCLE EXERCISER
K892888 · Bivona Medical Technologies · Oct 1989
CONTIMED II BIOFEEDBACK DEV TREAT OF URIN INCONTI
K891774 · Hollister, Inc. · Aug 1989