Cleared Traditional

K881207 - RES-Q 1, 2, 3, 4 AND 5

K881207 is an FDA 510(k) clearance for RES-Q 1, manufactured by Nova-Ventrx. The device is a Class 2 Anesthesiology device with product code BTM cleared through the Traditional 510(k) pathway after a 147-day FDA review.

K881207 · Nova-Ventrx · Anesthesiology device
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Aug 1988
Decision
147d
Days
Class 2
Risk

K881207 is an FDA 510(k) clearance for the RES-Q 1, 2, 3, 4 AND 5. Classified as Ventilator, Emergency, Manual (resuscitator) (product code BTM), Class II - Special Controls.

Submitted by Nova-Ventrx (Wheeling, US). The FDA issued a Cleared decision on August 15, 1988 after a review of 147 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.

FDA 510(k) Submission Details - K881207

510(k) Number K881207 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 1988
Decision Date August 15, 1988
Days to Decision 147 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
7d slower than avg
Panel avg: 140d · This submission: 147d
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 208
Devices cleared under the same product code (BTM) and FDA review panel - the closest regulatory comparables to K881207.
ADULT RESUSCITATOR WITH MASK AND FILTER
K884526 · Intertech/Ohio · Nov 1988
AMBU SPUR (SINGLE PATIENT USE RESUSCITATOR)
K883434 · Ambu, Inc. · Sep 1988
NONREBREATHING CIRCUIT
K882285 · Dryden Corp. · Aug 1988
CPR BAG
K881686 · Devolve Corp. · Jun 1988
RESUSCITATION BAG CONTROLLER (RBC)
K882278 · Physician Engineered Products, Inc. · Jun 1988
LIFEGUARD MOUTH TO MASK RESUSCITATOR
K881086 · Lifeguard Medical Products, Inc. · Apr 1988
K881207 · RES-Q 1, 2, 3, 4 AND 5
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