Cleared Traditional

K822213 - SIEMENS-ELEMA AB AGA REVIVATOR

K822213 is an FDA 510(k) clearance for SIEMENS-ELEMA AB AGA REVIVATOR, manufactured by Siemens Elema AB. The device is a Class 2 Anesthesiology device with product code BTM cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K822213 · Siemens Elema AB · Anesthesiology device
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Oct 1982
Decision
94d
Days
Class 2
Risk

K822213 is an FDA 510(k) clearance for the SIEMENS-ELEMA AB AGA REVIVATOR. Classified as Ventilator, Emergency, Manual (resuscitator) (product code BTM), Class II - Special Controls.

Submitted by Siemens Elema AB (Walker, US). The FDA issued a Cleared decision on October 28, 1982 after a review of 94 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5915 - 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 Siemens Elema AB devices

FDA 510(k) Submission Details - K822213

510(k) Number K822213 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 1982
Decision Date October 28, 1982
Days to Decision 94 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
46d faster than avg
Panel avg: 140d · This submission: 94d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BTM Device Classification - Class 2, Special Controls

Product Code BTM Ventilator, Emergency, Manual (resuscitator)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5915
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 - BTM Ventilator, Emergency, Manual (resuscitator)

All 76
Devices cleared under the same product code (BTM) and FDA review panel - the closest regulatory comparables to K822213.
CODE BLUE MANUAL RESUSCITATOR
K831885 · Vital Signs, Inc. · Sep 1983
SC-603 TWIN VALVE
K831486 · Instrumentation Industries, Inc. · Aug 1983
BE#1000-INSTANT ON/OFF O2 VALVE
K823408 · Instrumentation Industries, Inc. · Dec 1982
RESUSCITATION CIRCUIT
K812273 · Vital Signs, Inc. · Aug 1981
PMR-2 PURITAN MANUAL RESUSCITATOR
K802813 · Puritan Bennett Corp. · Dec 1980
RESUSCI-BAG-VALVE
K791468 · Concept, Inc. · Aug 1979