Cleared Traditional

K974036 - PATHWAY VAGINAL/RECTAL PERINEOMETER PROBE

K974036 is an FDA 510(k) clearance for PATHWAY VAGINAL/RECTAL PERINEOMETER PROBE, manufactured by The Prometheus Group. The device is a Class 2 Gastroenterology & Urology device with product code HIR cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K974036 · The Prometheus Group · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1997
Decision
59d
Days
Class 2
Risk

K974036 is an FDA 510(k) clearance for the PATHWAY VAGINAL/RECTAL PERINEOMETER PROBE. Classified as Perineometer (product code HIR), Class II - Special Controls.

Submitted by The Prometheus Group (Duxbury, US). The FDA issued a Cleared decision on December 22, 1997 after a review of 59 days - a notably fast clearance cycle.

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: 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 The Prometheus Group devices

FDA 510(k) Submission Details - K974036

510(k) Number K974036 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 24, 1997
Decision Date December 22, 1997
Days to Decision 59 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 131d · This submission: 59d
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 43
Devices cleared under the same product code (HIR) and FDA review panel - the closest regulatory comparables to K974036.
FEMISCAN CLINIC SYSTEM, MODEL FS-ICTRA AND FEMISCAN PERSONAL SYSTEM, MODEL FS-HMTR
K993411 · Mega Electronics , Ltd. · Jan 2000
PERIFORM
K981277 · Verimed Holdings, Inc. · Nov 1998
PERITRON PERINEOMETER MODEL 9300V OR 9300A
K983052 · Cardio Design Pty. , Ltd. · Oct 1998
PERINEOMETER & VAGINAL PROBE (BIOFEEDBACK MONITOR #20 AND VAGINAL PROBE)
K970145 · Biosearch Medical Products, Inc. · Aug 1997
PATHWAY ELECTROMYOGRAPH MODEL PATHWAY II/MR-10/MR-15/MR-20/MR-25
K960508 · The Prometheus Group · Jan 1997
PERINEOMETER
K960311 · Hollister, Inc. · Apr 1996