Cleared Traditional

K811238 - MODEL 560 SERIES VOLUMETRIC INFUSION

K811238 is the FDA 510(k) clearance for MODEL 560 SERIES VOLUMETRIC INFUSION by Y. It is a Class 2 General Hospital device (product code FRN) cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K811238 · Y · General Hospital

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Jun 1981

Decision

29d

Days

Class 2

Risk

K811238 is an FDA 510(k) clearance for the MODEL 560 SERIES VOLUMETRIC INFUSION. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Y (Walker, US). The FDA issued a Cleared decision on June 2, 1981 after a review of 29 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 Y devices

Submission Details

510(k) Number	K811238 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	May 04, 1981
Decision Date	June 02, 1981
Days to Decision	29 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	-
Third-party Review	No - reviewed directly by FDA
Combination Product	No
PCCP Authorized	No

Regulatory Context

Review time vs. panel average

100d faster than avg

Panel avg: 129d · This submission: 29d

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 447

Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K811238.

AMP MARK IV INFUSION PUMP

K811918 · American Medical Products, Inc. · Jul 1981

ENTRI ENTERAL FEEDING PUMP

K811739 · Biosearch Medical Products, Inc. · Jul 1981

OPEN LOOP AMBULATORY INFUSION DEVICE

K811774 · Cardiac Pacemakers, Inc. · Jul 1981

COMPUTER INTERFACE MODULE

K810295 · Y · Mar 1981

SIMPLICITY INFUSION PUMP MODEL 2100A

K803078 · Critikon Company, LLC · Jan 1981

TRAVENOL INFUSION PUMP-2M8016

K802901 · Travenol Laboratories, S.A. · Dec 1980

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 K811238

Walker, MI · US

Regulatory profile

78 submissions 78 cleared

100% clearance rate · Active in General Hospital

Data Intelligence Layer

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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.

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