Cleared Traditional

INFUTROL 7000 INFUSION PUMP (K832008) - FDA 510(k) Clearance

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

K832008 · Valleylab, Inc. · General Hospital

Download Printable Device Report (PDF)

Optimized for regulatory review, auditing and printing

Aug 1983

Decision

50d

Days

Class 2

Risk

K832008 is an FDA 510(k) clearance for the INFUTROL 7000 INFUSION PUMP. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Valleylab, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 12, 1983 after a review of 50 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 Valleylab, Inc. devices

Submission Details

510(k) Number	K832008 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 23, 1983
Decision Date	August 12, 1983
Days to Decision	50 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

79d faster than avg

Panel avg: 129d · This submission: 50d

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 232

Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K832008.

LIFECARE MICRO PUMP

K832289 · Abbott Laboratories · Sep 1983

GRASEBY DYNAMICS MS302 SYRINGE DRIVER

K832410 · Intermedics, Inc. · Sep 1983

FLO-GARD 8500 MICROINFUSION PUMP

K832166 · Travenol Laboratories, S.A. · Aug 1983

PROMINJET PUMP

K832120 · Abbott Laboratories · Aug 1983

FLO-GARD 6100 VOLUMETRIC INFUSION PUMP

K831258 · Travenol Laboratories, S.A. · Jun 1983

Y-TYPE BACKCHECK MICROBORE EXTEN. SET

K831203 · Abbott Laboratories · Jun 1983

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K832008

Valleylab, Inc.

Mchenry, IL · US

Regulatory profile

94 submissions 93 cleared

99% clearance rate · Active in General Hospital

Data Intelligence Layer

This record restructures FDA 510(k) public data into device-level regulatory intelligence - enabling comparison across product codes, clearance pathways, review times and manufacturer patterns.

Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . Updated monthly.

Verify on FDA.gov

510k Database

510(k) clearances indexed 175,450

Regulatory data since 1976

FDA monthly sync Active