Cleared Traditional

K781926 - VENTILATOR, INFANT MODEL 100

K781926 is an FDA 510(k) clearance for VENTILATOR, manufactured by Healthdyne, Inc.. The device is a Class 2 Anesthesiology device with product code CBK cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K781926 · Healthdyne, Inc. · Anesthesiology device
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Dec 1978
Decision
43d
Days
Class 2
Risk

K781926 is an FDA 510(k) clearance for the VENTILATOR, INFANT MODEL 100. Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by Healthdyne, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 21, 1978 after a review of 43 days - a notably fast clearance 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: 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 Healthdyne, Inc. devices

FDA 510(k) Submission Details - K781926

510(k) Number K781926 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 1978
Decision Date December 21, 1978
Days to Decision 43 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
97d faster than avg
Panel avg: 140d · This submission: 43d
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 326
Devices cleared under the same product code (CBK) and FDA review panel - the closest regulatory comparables to K781926.
CAM-10 PVV PORTABLE VOLUME VENTILATOR
K791033 · Lifecare Services, Inc. · Jul 1979
VENTIMETER CONTROLLER
K790732 · Narco Air-Shields · Apr 1979
VENTIMETER VENTILATOR
K790733 · Narco Air-Shields · Apr 1979
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