Cleared Traditional

K981277 - PERIFORM

K981277 is an FDA 510(k) clearance for PERIFORM, manufactured by Verimed Holdings, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code HIR cleared through the Traditional 510(k) pathway after a 226-day FDA review.

K981277 · Verimed Holdings, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1998
Decision
226d
Days
Class 2
Risk

K981277 is an FDA 510(k) clearance for the PERIFORM. Classified as Perineometer (product code HIR), Class II - Special Controls.

Submitted by Verimed Holdings, Inc. (Coral Springs, US). The FDA issued a Cleared decision on November 20, 1998 after a review of 226 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Verimed Holdings, Inc. devices

FDA 510(k) Submission Details - K981277

510(k) Number K981277 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 1998
Decision Date November 20, 1998
Days to Decision 226 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
95d slower than avg
Panel avg: 131d · This submission: 226d
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 42
Devices cleared under the same product code (HIR) and FDA review panel - the closest regulatory comparables to K981277.
INCARE PRESSURE BIOFEEDBACK VAGINAL PRESSURE PROBE AND ANAL PRESSURE PROBE
K013653 · Hollister, Inc. · Mar 2002
REFLEX TREATMENT SYSTEM
K994079 · Deschutes Medical Products, Inc. · Mar 2000
FEMISCAN CLINIC SYSTEM, MODEL FS-ICTRA AND FEMISCAN PERSONAL SYSTEM, MODEL FS-HMTR
K993411 · Mega Electronics , Ltd. · Jan 2000
PERITRON PERINEOMETER MODEL 9300V OR 9300A
K983052 · Cardio Design Pty. , Ltd. · Oct 1998
PATHWAY VAGINAL/RECTAL PERINEOMETER PROBE
K974036 · The Prometheus Group · Dec 1997
PERINEOMETER & VAGINAL PROBE (BIOFEEDBACK MONITOR #20 AND VAGINAL PROBE)
K970145 · Biosearch Medical Products, Inc. · Aug 1997