Cleared Traditional

K811774 - OPEN LOOP AMBULATORY INFUSION DEVICE

K811774 is an FDA 510(k) clearance for OPEN LOOP AMBULATORY INFUSION DEVICE, manufactured by Cardiac Pacemakers, Inc.. The device is a Class 2 General Hospital device with product code FRN cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K811774 · Cardiac Pacemakers, Inc. · General Hospital
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Jul 1981
Decision
17d
Days
Class 2
Risk

K811774 is an FDA 510(k) clearance for the OPEN LOOP AMBULATORY INFUSION DEVICE. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Cardiac Pacemakers, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 10, 1981 after a review of 17 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.

FDA 510(k) Submission Details - K811774

510(k) Number K811774 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 1981
Decision Date July 10, 1981
Days to Decision 17 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
112d faster than avg
Panel avg: 129d · This submission: 17d
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 803
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K811774.
GUARDIAN, VOLUMETRIC CONTROL DELIVERY
K811933 · Avi, Inc. · Jul 1981
RAZEL MODEL C
K811272 · Razel Scientific Instruments, Inc. · Jul 1981
ENTRI ENTERAL FEEDING PUMP
K811739 · Biosearch Medical Products, Inc. · Jul 1981
OFFENBACK REVERSIBLE BARIUM PUMP
K803183 · The Offenback Co. · Jun 1981
MODEL 560 SERIES VOLUMETRIC INFUSION
K811238 · Y · Jun 1981
COMPUTER INTERFACE MODULE
K810295 · Y · Mar 1981
K811774 · OPEN LOOP AMBULATORY INFUSION DEVICE
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