Cleared Traditional

K881483 - AIRWAY-CIRCULATION EVALUATOR

K881483 is an FDA 510(k) clearance for AIRWAY-CIRCULATION EVALUATOR, manufactured by Resuscitation Ace, Inc.. The device is a Class 2 Anesthesiology device with product code BTM cleared through the Traditional 510(k) pathway after a 252-day FDA review.

K881483 · Resuscitation Ace, Inc. · Anesthesiology device
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Dec 1988
Decision
252d
Days
Class 2
Risk

K881483 is an FDA 510(k) clearance for the AIRWAY-CIRCULATION EVALUATOR. Classified as Ventilator, Emergency, Manual (resuscitator) (product code BTM), Class II - Special Controls.

Submitted by Resuscitation Ace, Inc. (Denver, US). The FDA issued a Cleared decision on December 16, 1988 after a review of 252 days - an extended review cycle.

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.

FDA 510(k) Submission Details - K881483

510(k) Number K881483 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 1988
Decision Date December 16, 1988
Days to Decision 252 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
112d slower than avg
Panel avg: 140d · This submission: 252d
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 164
Devices cleared under the same product code (BTM) and FDA review panel - the closest regulatory comparables to K881483.
MANUAL DISPOSABLE PULMONARY RESUSCITATOR
K895169 · F.L.W. Plastics, Inc. · Oct 1989
SINGLE PATIENT USE DISPOSABLE MANUAL RESUSCITATOR
K894365 · Puritan Bennett Corp. · Oct 1989
PULMONARY RESUSCITATOR, MODIFICATION
K892221 · Life Design Systems, Inc. · May 1989
PULMANEX TM (NEO-NATAL SIZE)
K884068 · Life Design Systems, Inc. · Nov 1988
AMBU SPUR (SINGLE PATIENT USE RESUSCITATOR)
K883434 · Ambu, Inc. · Sep 1988
NONREBREATHING CIRCUIT
K882285 · Dryden Corp. · Aug 1988
K881483 · AIRWAY-CIRCULATION EVALUATOR
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