Cleared Traditional

K842610 - GUIDELINES FOR PEDIATRIC ANESTHESIA

K842610 is the FDA 510(k) clearance for GUIDELINES FOR PEDIATRIC ANESTHESIA by Critical Care Micro Computing. It is a Class 2 Anesthesiology device (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.

View all Critical Care Micro Computing devices

Submission Details

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.

Device Classification

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 54
Devices cleared under the same product code (CAC) and FDA review panel - the closest regulatory comparables to K842610.
PLEURA-GARD ATS
K871568 · Conmedcorp · Jun 1987
THORA-DRAIN(R) ABT SYSTEM
K871624 · Sherwood Medical Co. · Jun 1987
ARGYLE SENTINEL SEAL AUTOTRANSFUSION SYSTEM
K864374 · Sherwood Medical Co. · Mar 1987
SORENSON CATALOG #IFL-120S
K811228 · Sorensen Research · Jun 1981
TRAUMA DRAINAGE SET 72T-28TTC
K781550 · Sorensen Research · Oct 1978
TRAUMA DRAINAGE SET 72T-32TTC
K781551 · Sorensen Research · Oct 1978