Cleared Traditional

SIGMA SYRINGE DELIVERY SYSTEM(MULTI-DOSER REV. 1/MULTI-DOSER REV. II/SINGLE-DOSER REV. 1-10/SINGLE-DOSER REV. 1-20/ (K962709) - FDA 510(k) Clearance

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

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

Submission Details

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
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.

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 K962709.
ABBOTT LIFECARE STANDARD TUBING INFUSION PUMP
K983838 · Abbott Laboratories · Nov 1998
ABBOTT GEMSTAR IV INFUSION PUMP
K974778 · Abbott Laboratories · Mar 1998
SMITH & NEPHEW DYONICS INTELIJET REUSABLE CANNULAS
K980092 · Smith & Nephew, Inc. · Mar 1998
COLLEAGUE 2 VOLUMETRIC INFUSION PUMP(DUAL CHANNEL)/COLLEAGUE 3 VOLUMETRIC INFUSION PUMP(TREE CHANNEL)
K961703 · Baxter Healthcare Corp · Jul 1996
ABBOTT XL3M INFUSION PUMP
K952799 · Abbott Laboratories · Jan 1996
VOLUMETRIC INFUSION PUMP
K953098 · Baxter Healthcare Corp · Dec 1995