Cleared Traditional

SIGMA 8000 AND SIGMA 8002 (K942162) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

Device Classification

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 220
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K942162.
LIFECARE 175 INFUSER, MODIFICATION
K944190 · Abbott Laboratories · May 1995
PLUM XL INFUSION PUMP
K944733 · Abbott Laboratories · Feb 1995
ABBOTT LTE INFUSION PUMP
K944125 · Abbott Laboratories · Dec 1994
PROVIDER ANNE INFUSER
K922702 · Abbott Laboratories · Jul 1994
BARD APII PUMP
K926385 · C.R. Bard, Inc. · Apr 1994
HI-FLO INFUSION PUMP
K934671 · Abbott Laboratories · Mar 1994