Cleared Traditional

K121747 - FACEFIT AND FACEFIT PORTED NON-INVASIVE...

K121747 is an FDA 510(k) clearance for FACEFIT AND FACEFIT PORTED NON-INVASIVE..., manufactured by Intersurgical Incorporated. The device is a Class 2 Anesthesiology device with product code BZD cleared through the Traditional 510(k) pathway after a 273-day FDA review.

K121747 · Intersurgical Incorporated · Anesthesiology device
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Mar 2013
Decision
273d
Days
Class 2
Risk

K121747 is an FDA 510(k) clearance for the FACEFIT AND FACEFIT PORTED NON-INVASIVE VENTILATION MASKS. Classified as Ventilator, Non-continuous (respirator) (product code BZD), Class II - Special Controls.

Submitted by Intersurgical Incorporated (Liverpool, US). The FDA issued a Cleared decision on March 14, 2013 after a review of 273 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5905 - 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 Intersurgical Incorporated devices

FDA 510(k) Submission Details - K121747

510(k) Number K121747 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 2012
Decision Date March 14, 2013
Days to Decision 273 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
133d slower than avg
Panel avg: 140d · This submission: 273d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BZD Device Classification - Class 2, Special Controls

Product Code BZD Ventilator, Non-continuous (respirator)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5905
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 - BZD Ventilator, Non-continuous (respirator)

All 307
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