Cleared Traditional

K782019 - CUTTER 888-00 INFUSION PUMP

K782019 is an FDA 510(k) clearance for CUTTER 888-00 INFUSION PUMP, manufactured by Sigmamotor, Inc.. The device is a Class 2 General Hospital device with product code FRN cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K782019 · Sigmamotor, Inc. · General Hospital
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Jan 1979
Decision
43d
Days
Class 2
Risk

K782019 is an FDA 510(k) clearance for the CUTTER 888-00 INFUSION PUMP. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Sigmamotor, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 17, 1979 after a review of 43 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 Sigmamotor, Inc. devices

FDA 510(k) Submission Details - K782019

510(k) Number K782019 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 1978
Decision Date January 17, 1979
Days to Decision 43 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
86d faster than avg
Panel avg: 129d · This submission: 43d
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 624
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K782019.
MODEL IV6000 INFUSION PUMP
K790332 · Valleylab, Inc. · Apr 1979
IVAC 630 VOLUMETRIC INFUSION PUMP
K790373 · Y · Apr 1979
INFUSION PUMP, MODEL AS*5
K782034 · Baxter Healthcare Corp · Feb 1979
INFUSION PUMP, PEDIATRIC MODEL 301
K781171 · Imed Corp. · Aug 1978
INFUSION PUMP
K780503 · Air-Shields, Inc. · Apr 1978
INFUSION APPARATUS, POWERED
K780086 · Ohio Medical Products · Jan 1978