Cleared Traditional

K926191 - SIGMA 7000 AND SIGMA70002

K926191 is an FDA 510(k) clearance for SIGMA 7000 AND SIGMA70002, manufactured by Sigma. The device is a Class 2 General Hospital device with product code FRN cleared through the Traditional 510(k) pathway after a 265-day FDA review.

K926191 · Sigma · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1993
Decision
265d
Days
Class 2
Risk

K926191 is an FDA 510(k) clearance for the SIGMA 7000 AND SIGMA70002. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Sigma (Medina, US). The FDA issued a Cleared decision on August 31, 1993 after a review of 265 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5725 - the FDA general hospital 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 General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

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FDA 510(k) Submission Details - K926191

510(k) Number K926191 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 1992
Decision Date August 31, 1993
Days to Decision 265 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
136d slower than avg
Panel avg: 129d · This submission: 265d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FRN Device Classification - Class 2, Special Controls

Product Code FRN Pump, Infusion
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5725
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 Hospital devices follow this clearance model.

Regulatory Peers - FRN Pump, Infusion

All 603
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K926191.
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