Cleared Traditional

K910081 - TBD

K910081 is the FDA 510(k) clearance for TBD by Empi. It is a Class 2 Gastroenterology & Urology device (product code KPI) cleared through the Traditional 510(k) pathway after a 187-day FDA review.

K910081 · Empi · Gastroenterology & Urology device
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Jul 1991
Decision
187d
Days
Class 2
Risk

K910081 is an FDA 510(k) clearance for the TBD. Classified as Stimulator, Electrical, Non-implantable, For Incontinence (product code KPI), Class II - Special Controls.

Submitted by Empi (Arden Hills, US). The FDA issued a Cleared decision on July 15, 1991 after a review of 187 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5320 - 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 Empi devices

Submission Details

510(k) Number K910081 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 09, 1991
Decision Date July 15, 1991
Days to Decision 187 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
57d slower than avg
Panel avg: 130d · This submission: 187d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KPI Stimulator, Electrical, Non-implantable, For Incontinence
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5320
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 - KPI Stimulator, Electrical, Non-implantable, For Incontinence

All 47
Devices cleared under the same product code (KPI) and FDA review panel - the closest regulatory comparables to K910081.
INNOVA RECTAL STIMULATON ELECTRODE
K954272 · Empi · Apr 1996
INCARE PRS 9300 PELVIC FL THERA SYST/TREAT URI INC
K930530 · Hollister, Inc. · Oct 1995
INNOVA PELVIC FLOOR STIMULATION SYSTEM
K941911 · Empi · Jan 1995
MICROGYN II ELEC STIM DEVICE TREAT OF URIN INCONTI
K891773 · Hollister, Inc. · Aug 1989
CATR(TM)-H CARDIOTOMY HOLDER
K874867 · Bentley Laboratories, Inc. · Feb 1988
RADIOISOTOPE CALIBRATOR (CRCO-22NB)
K761145 · G.D. Searle and Co. · Dec 1976