Cleared Traditional

K950766 - SIGMA 8000 AND SIGMA 8002

K950766 is an FDA 510(k) clearance for SIGMA 8000 AND SIGMA 8002, manufactured by Sigma Intl. General Medical Apparatus, Inc.. The device is a Class 2 General Hospital device with product code FRN cleared through the Traditional 510(k) pathway after a 33-day FDA review.

K950766 · Sigma Intl. General Medical Apparatus, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1995
Decision
33d
Days
Class 2
Risk

K950766 is an FDA 510(k) clearance for the SIGMA 8000 AND SIGMA 8002. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Sigma Intl. General Medical Apparatus, Inc. (Medina, US). The FDA issued a Cleared decision on March 22, 1995 after a review of 33 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Sigma Intl. General Medical Apparatus, Inc. devices

FDA 510(k) Submission Details - K950766

510(k) Number K950766 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 17, 1995
Decision Date March 22, 1995
Days to Decision 33 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
96d faster than avg
Panel avg: 129d · This submission: 33d
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 612
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