Cleared Traditional

K861136 - INTERSTIM 100 SYSTEM

K861136 is an FDA 510(k) clearance for INTERSTIM 100 SYSTEM, manufactured by Buckman Co., Inc.. The device is a Class 2 Physical Medicine device with product code IPF cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K861136 · Buckman Co., Inc. · Physical Medicine device
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Jul 1986
Decision
105d
Days
Class 2
Risk

K861136 is an FDA 510(k) clearance for the INTERSTIM 100 SYSTEM. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Buckman Co., Inc. (Martinez, US). The FDA issued a Cleared decision on July 9, 1986 after a review of 105 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5850 - the FDA physical medicine 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 Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Buckman Co., Inc. devices

FDA 510(k) Submission Details - K861136

510(k) Number K861136 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received March 26, 1986
Decision Date July 09, 1986
Days to Decision 105 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
10d faster than avg
Panel avg: 115d · This submission: 105d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IPF Device Classification - Class 2, Special Controls

Product Code IPF Stimulator, Muscle, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5850
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 Physical Medicine devices follow this clearance model.

Regulatory Peers - IPF Stimulator, Muscle, Powered

All 277
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K861136.
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K864625 · Medical Devices, Inc. · Dec 1986
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K864010 · Empi · Dec 1986
RICH-MAR IF 200
K854485 · Rich-Mar Corp. · Jun 1986
HV-4
K853154 · Robert Bosch Corp. · Mar 1986
MIDIFICATION SYS*STIM 207 (MODEL-ME207)
K855249 · Mettler Electronics Corp. · Mar 1986