Cleared Traditional

K781160 - VENTILATOR, MINILUNG

K781160 is an FDA 510(k) clearance for VENTILATOR, manufactured by Thompson Respiration Products, Inc.. The device is a Class 2 Anesthesiology device with product code CBK cleared through the Traditional 510(k) pathway after a 161-day FDA review.

K781160 · Thompson Respiration Products, Inc. · Anesthesiology device
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Dec 1978
Decision
161d
Days
Class 2
Risk

K781160 is an FDA 510(k) clearance for the VENTILATOR, MINILUNG. Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by Thompson Respiration Products, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 13, 1978 after a review of 161 days - an extended review cycle.

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.

FDA 510(k) Submission Details - K781160

510(k) Number K781160 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 1978
Decision Date December 13, 1978
Days to Decision 161 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
21d slower than avg
Panel avg: 140d · This submission: 161d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CBK Device Classification - Class 2, Special Controls

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.

Regulatory Peers - CBK Ventilator, Continuous, Facility Use

All 455
Devices cleared under the same product code (CBK) and FDA review panel - the closest regulatory comparables to K781160.
VENTIMETER CONTROLLER
K790732 · Narco Air-Shields · Apr 1979
VENTIMETER VENTILATOR
K790733 · Narco Air-Shields · Apr 1979
VENTILATOR, INFANT MODEL 100
K781926 · Healthdyne, Inc. · Dec 1978
INFANT VENTILATOR MODEL 100
K780188 · Sechrist Industries, Inc. · Apr 1978
CRITICAL CARE VENTILATOR 2
K772065 · Ohio Medical Products · Nov 1977
MVP-10 PEDIATRIC/NEONATAL VENTILATOR
K760663 · Air-Shields, Inc. · Sep 1976
K781160 · VENTILATOR, MINILUNG
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