Cleared Traditional

K092687 - VENTI.PLUS HYPERINFLATION BAG SYSTEM WI...

K092687 is an FDA 510(k) clearance for VENTI.PLUS HYPERINFLATION BAG SYSTEM WI..., manufactured by A Plus Medical. The device is a Class 2 Anesthesiology device with product code NHK cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K092687 · A Plus Medical · Anesthesiology device
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Nov 2009
Decision
83d
Days
Class 2
Risk

K092687 is an FDA 510(k) clearance for the VENTI.PLUS HYPERINFLATION BAG SYSTEM WITH PRESSURE MANOMETER. Classified as Resuscitator, Manual, Non Self-inflating (product code NHK), Class II - Special Controls.

Submitted by A Plus Medical (Carlsbad, US). The FDA issued a Cleared decision on November 23, 2009 after a review of 83 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 A Plus Medical devices

FDA 510(k) Submission Details - K092687

510(k) Number K092687 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 2009
Decision Date November 23, 2009
Days to Decision 83 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
57d faster than avg
Panel avg: 140d · This submission: 83d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NHK Device Classification - Class 2, Special Controls

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.

Regulatory Peers - NHK Resuscitator, Manual, Non Self-inflating

Devices cleared under the same product code (NHK) and FDA review panel - the closest regulatory comparables to K092687.
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