Cleared Traditional

K790605 - RESPIRAOTR

K790605 is the FDA 510(k) clearance for RESPIRAOTR by Lifecare Services, Inc.. It is a Class 2 Anesthesiology device (product code CBK) cleared through the Traditional 510(k) pathway after a 96-day FDA review.

K790605 · Lifecare Services, Inc. · Anesthesiology device
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Jul 1979
Decision
96d
Days
Class 2
Risk

K790605 is an FDA 510(k) clearance for the RESPIRAOTR, CAM-10 RBL. Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by Lifecare Services, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 3, 1979 after a review of 96 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5895 - 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 Lifecare Services, Inc. devices

Submission Details

510(k) Number K790605 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 1979
Decision Date July 03, 1979
Days to Decision 96 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 140d · This submission: 96d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CBK Ventilator, Continuous, Facility Use
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5895
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.