Cleared Traditional

K842610 - GUIDELINES FOR PEDIATRIC ANESTHESIA

K842610 is an FDA 510(k) clearance for GUIDELINES FOR PEDIATRIC ANESTHESIA, manufactured by Critical Care Micro Computing. The device is a Class 2 Anesthesiology device with product code CAC cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K842610 · Critical Care Micro Computing · Anesthesiology device
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Oct 1984
Decision
91d
Days
Class 2
Risk

K842610 is an FDA 510(k) clearance for the GUIDELINES FOR PEDIATRIC ANESTHESIA. Classified as Apparatus, Autotransfusion (product code CAC), Class II - Special Controls.

Submitted by Critical Care Micro Computing (Mchenry, US). The FDA issued a Cleared decision on October 4, 1984 after a review of 91 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5830 - the FDA anesthesiology and respiratory 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K842610

510(k) Number K842610 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 1984
Decision Date October 04, 1984
Days to Decision 91 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 140d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CAC Device Classification - Class 2, Special Controls

Product Code CAC Apparatus, Autotransfusion
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5830
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 Anesthesiology devices follow this clearance model.

Regulatory Peers - CAC Apparatus, Autotransfusion

All 180
Devices cleared under the same product code (CAC) and FDA review panel - the closest regulatory comparables to K842610.
PLEUR-EVAC II AUTOTRANSFUSION SYSTEM
K854301 · Deknatel, Inc. · Nov 1985
CELL SAVER SUCTION SYSTEM
K852425 · Haemonetics Corp. · Sep 1985
PLEUR-EVAC AUTOTRANSFUSION SYSTEM -TENTATIVE
K851024 · Pfizer, Inc. · May 1985
PLEURAL DRAINAGE SYS #PDS-100-4
K831849 · American Bentley · Dec 1983
BT 795/A AUTOTRANS
K830735 · Electromedics, Inc. · May 1983
AUTOTRANS BT795
K812292 · Electromedics, Inc. · Oct 1981
K842610 · GUIDELINES FOR PEDIATRIC ANESTHESIA
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