Cleared Traditional

K942162 - SIGMA 8000 AND SIGMA 8002

K942162 is an FDA 510(k) clearance for SIGMA 8000 AND SIGMA 8002, manufactured by Sigma Intl.. The device is a Class 2 General Hospital device with product code FRN cleared through the Traditional 510(k) pathway after a 169-day FDA review.

K942162 · Sigma Intl. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1994
Decision
169d
Days
Class 2
Risk

K942162 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. (Medina, US). The FDA issued a Cleared decision on October 20, 1994 after a review of 169 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.

View all Sigma Intl. devices

FDA 510(k) Submission Details - K942162

510(k) Number K942162 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 1994
Decision Date October 20, 1994
Days to Decision 169 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
40d slower than avg
Panel avg: 129d · This submission: 169d
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 555
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K942162.
SMART DOSE(TM)
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LOCKBOX
K942161 · Pharmacia Deltec, Inc. · Aug 1994
PROVIDER ANNE INFUSER
K922702 · Abbott Laboratories · Jul 1994
CORPAK ENTERAL PUMP
K932847 · Corpak Co. · Jun 1994