Cleared Traditional

K013308 - VENTLAB HYPERINFLATION BAG SYSTEM (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K013308 · Ventlab Corp. · Anesthesiology device
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Dec 2001
Decision
77d
Days
Class 2
Risk

K013308 is an FDA 510(k) clearance for the VENTLAB HYPERINFLATION BAG SYSTEM. Classified as Resuscitator, Manual, Non Self-inflating (product code NHK), Class II - Special Controls.

Submitted by Ventlab Corp. (Mocksville, US). The FDA issued a Cleared decision on December 20, 2001 after a review of 77 days - a notably fast clearance 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: 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 Ventlab Corp. devices

Submission Details

510(k) Number K013308 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 2001
Decision Date December 20, 2001
Days to Decision 77 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 139d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NHK Resuscitator, Manual, Non Self-inflating
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5905
Definition A Non Self-inflating Manual Resuscitator, Also Called A Hyperinflation System, Is A Manual Ventilator Intended To Ventilate A Patient By Forcing A Volume Of Fresh Gas Into The Patient Via Compression Of The Ventilator Bag; A Source Of Compressed Breathing Gas Is Required To Inflate The Bag.
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.