Cleared Traditional

K861324 - PATIENTCARE 1000

K861324 is an FDA 510(k) clearance for PATIENTCARE 1000, manufactured by Criticare Technologies Corp.. The device is a Class 2 General Hospital device with product code FRN cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K861324 · Criticare Technologies Corp. · General Hospital
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Jun 1986
Decision
62d
Days
Class 2
Risk

K861324 is an FDA 510(k) clearance for the PATIENTCARE 1000. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Criticare Technologies Corp. (Sparks, US). The FDA issued a Cleared decision on June 9, 1986 after a review of 62 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 Criticare Technologies Corp. devices

FDA 510(k) Submission Details - K861324

510(k) Number K861324 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 1986
Decision Date June 09, 1986
Days to Decision 62 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
67d faster than avg
Panel avg: 129d · This submission: 62d
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 619
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K861324.
BARD HARVARD(TM) PCA JR INTERMITTENT INFUSION PUMP
K863683 · C.R. Bard, Inc. · Oct 1986
MODEL PC-2 VOLUMETRIC INFUSION PUMP/CONTROLLER
K862295 · Imed Corp. · Sep 1986
SYRINGE INFUSION PUMP
K860353 · Travenol Laboratories, S.A. · Sep 1986
SOF SET, MODELS 111 AND 112
K861436 · Pacesetter Systems · Jun 1986
SOF SET, MODELS 113 AND 114
K860857 · Pacesetter Systems · May 1986
BECTON DICKINSON PCAINFUSER
K861007 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1986