Cleared Traditional

K960492 - SI CONTROLLER MODEL SI 500

K960492 is an FDA 510(k) clearance for SI CONTROLLER MODEL SI 500, manufactured by I.C Medical, Inc.. The device is a Class 2 General & Plastic Surgery device with product code BTA cleared through the Traditional 510(k) pathway after a 325-day FDA review.

K960492 · I.C Medical, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
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Dec 1996
Decision
325d
Days
Class 2
Risk

K960492 is an FDA 510(k) clearance for the SI CONTROLLER MODEL SI 500. Classified as Pump, Portable, Aspiration (manual Or Powered) (product code BTA), Class II - Special Controls.

Submitted by I.C Medical, Inc. (Glendale, US). The FDA issued a Cleared decision on December 23, 1996 after a review of 325 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4780 - the FDA general and plastic surgery 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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all I.C Medical, Inc. devices

FDA 510(k) Submission Details - K960492

510(k) Number K960492 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 1996
Decision Date December 23, 1996
Days to Decision 325 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
210d slower than avg
Panel avg: 115d · This submission: 325d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BTA Device Classification - Class 2, Special Controls

Product Code BTA Pump, Portable, Aspiration (manual Or Powered)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4780
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 General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - BTA Pump, Portable, Aspiration (manual Or Powered)

All 85
Devices cleared under the same product code (BTA) and FDA review panel - the closest regulatory comparables to K960492.
S-SCORT (2500)
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K965059 · Thomas Industries · Mar 1997
GI SUPPLY PARACENTESIS PUMP
K970186 · Gi Supply · Feb 1997
UIMAT PUMP
K953132 · KARL STORZ Endoscopy-America, Inc. · Aug 1995
AMBU PORTABLE SUCTION UNIT
K932031 · Ambu, Inc. · May 1995
ASPIRATOR, CONTINUOUS & PROGRAMMABLE INTERMITTENT
K951423 · Impact Instrumentation, Inc. · Apr 1995