Cleared Traditional

K894612 - INTERTECH NEWBORN HYPERINFLATION BAG SYSTEM (FDA 510(k) Clearance)

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

K894612 · Intertech Resources, Inc. · Anesthesiology device
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Sep 1989
Decision
50d
Days
Class 2
Risk

K894612 is an FDA 510(k) clearance for the INTERTECH NEWBORN HYPERINFLATION BAG SYSTEM. Classified as Resuscitator, Manual, Non Self-inflating (product code NHK), Class II - Special Controls.

Submitted by Intertech Resources, Inc. (Fort Myers, US). The FDA issued a Cleared decision on September 8, 1989 after a review of 50 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 Intertech Resources, Inc. devices

Submission Details

510(k) Number K894612 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 1989
Decision Date September 08, 1989
Days to Decision 50 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
89d faster than avg
Panel avg: 139d · This submission: 50d
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.