Cleared Traditional

K962709 - SIGMA SYRINGE DELIVERY SYSTEM(MULTI-DOSER REV. 1/MULTI-DOSER REV. II/SINGLE-DOSER REV. 1-10/SINGLE-DOSER REV. 1-20/

K962709 is an FDA 510(k) clearance for SIGMA SYRINGE DELIVERY SYSTEM(MULTI-DOS..., 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 87-day FDA review.

K962709 · Sigma Intl. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1996
Decision
87d
Days
Class 2
Risk

K962709 is an FDA 510(k) clearance for the SIGMA SYRINGE DELIVERY SYSTEM(MULTI-DOSER REV. 1/MULTI-DOSER REV. II/SINGLE-D.... 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 7, 1996 after a review of 87 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. devices

FDA 510(k) Submission Details - K962709

510(k) Number K962709 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 1996
Decision Date October 07, 1996
Days to Decision 87 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 129d · This submission: 87d
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 554
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K962709.
MODELS IDA-2 PLUS AND IPT-1
K961862 · Bio-Tek Instruments, Inc. · Feb 1997
DISETRONIC D-MODEM
K961975 · Disetronic Medical Systems · Jan 1997
GEMINI PC-ITX
K960512 · Imed Corp. · Nov 1996
CADD-PRIZM MODEL 6100 PUMP
K960826 · Sims Deltec, Inc. · Aug 1996
MODEL 1200 ABMULATORY INFUSION PUMP
K961263 · Patient Solutions, Inc. · Aug 1996
MEDFUSION MODEL 2001 SYRINGE INFUSION PUMP
K955231 · Medex, Inc. · Jul 1996