Cleared Traditional

K800114 - SIEMENS-ELEMA AB MANUAL VENTILATION

K800114 is an FDA 510(k) clearance for SIEMENS-ELEMA AB MANUAL VENTILATION, manufactured by Siemens Elema AB. The device is a Class 2 Anesthesiology device with product code CBK cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K800114 · Siemens Elema AB · Anesthesiology device
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Mar 1980
Decision
48d
Days
Class 2
Risk

K800114 is an FDA 510(k) clearance for the SIEMENS-ELEMA AB MANUAL VENTILATION. Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by Siemens Elema AB (Mchenry, US). The FDA issued a Cleared decision on March 5, 1980 after a review of 48 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 Siemens Elema AB devices

FDA 510(k) Submission Details - K800114

510(k) Number K800114 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 17, 1980
Decision Date March 05, 1980
Days to Decision 48 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
92d faster than avg
Panel avg: 140d · This submission: 48d
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 239
Devices cleared under the same product code (CBK) and FDA review panel - the closest regulatory comparables to K800114.
INFANT VENTILATOR, (RESPIRATOR) PLAN B
K802583 · Healthdyne, Inc. · Dec 1980
BABYBIRD 2 VENTILATOR
K802087 · Bird Products Corp. · Oct 1980
MOD. 300 ANESTH. VOL. VENTILATOR W/ALARM
K800650 · Hospal Medical Corp. · Apr 1980
VENTILATOR, INFANT MODEL 100
K781926 · Healthdyne, Inc. · Dec 1978
CRITICAL CARE VENTILATOR 2
K772065 · Ohio Medical Products · Nov 1977
MVP-10 PEDIATRIC/NEONATAL VENTILATOR
K760663 · Air-Shields, Inc. · Sep 1976