Cleared Traditional

K970785 - SIMS HYPERINFLATION BAG SYSTEM

K970785 is an FDA 510(k) clearance for SIMS HYPERINFLATION BAG SYSTEM, manufactured by Sims. The device is a Class 2 Anesthesiology device with product code NHK cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K970785 · Sims · Anesthesiology device
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Jun 1997
Decision
101d
Days
Class 2
Risk

K970785 is an FDA 510(k) clearance for the SIMS HYPERINFLATION BAG SYSTEM. Classified as Resuscitator, Manual, Non Self-inflating (product code NHK), Class II - Special Controls.

Submitted by Sims (Fort Myers, US). The FDA issued a Cleared decision on June 13, 1997 after a review of 101 days - within the typical 510(k) review window.

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 Sims devices

FDA 510(k) Submission Details - K970785

510(k) Number K970785 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 1997
Decision Date June 13, 1997
Days to Decision 101 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 140d · This submission: 101d
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 K970785.
MODIFICATION TO VENTLAB HYPERINFLATION BAG SYSTEM
K020281 · Ventlab Corp. · Feb 2002
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K013308 · Ventlab Corp. · Dec 2001
SIMS INTERTECH HYPERINFLATION BAG SYSTEM
K952214 · Intertech Resources, Inc. · Jun 1995
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K942571 · Med-Plastics Intl., Inc. · Jun 1994
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K894612 · Intertech Resources, Inc. · Sep 1989
DISP. HYPERINFLATION BAG SYSTEM
K813317 · Intec Medical, Inc. · Mar 1982