Cleared Traditional

K970780 - ONE-WAY VALVE (WITH CONNECTOR)

K970780 is an FDA 510(k) clearance for ONE-WAY VALVE (WITH CONNECTOR), manufactured by Instrumentation Industries, Inc.. The device is a Class 2 Anesthesiology device with product code CBP cleared through the Traditional 510(k) pathway after a 198-day FDA review.

K970780 · Instrumentation Industries, Inc. · Anesthesiology device
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Sep 1997
Decision
198d
Days
Class 2
Risk

K970780 is an FDA 510(k) clearance for the ONE-WAY VALVE (WITH CONNECTOR). Classified as Valve, Non-rebreathing (product code CBP), Class II - Special Controls.

Submitted by Instrumentation Industries, Inc. (Bethel Park, US). The FDA issued a Cleared decision on September 18, 1997 after a review of 198 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5870 - 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 Instrumentation Industries, Inc. devices

FDA 510(k) Submission Details - K970780

510(k) Number K970780 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 1997
Decision Date September 18, 1997
Days to Decision 198 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
58d slower than avg
Panel avg: 140d · This submission: 198d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CBP Device Classification - Class 2, Special Controls

Product Code CBP Valve, Non-rebreathing
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5870
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 - CBP Valve, Non-rebreathing

All 62
Devices cleared under the same product code (CBP) and FDA review panel - the closest regulatory comparables to K970780.
RESPAIDE
K980052 · Emergency Filtration Products, Inc. · Aug 1998
RONDEX CPR ISO-SHIELD
K981169 · Rondex Products, Inc. · May 1998
NON-REBREATHING 'T' (BE 117)
K973066 · Instrumentation Industries, Inc. · Feb 1998
CPROTECTOR 2000
K960587 · Certified Safety Mfg., Inc. · Jul 1997
SPIRACLE TECHNOLOGY - MODEL 302 OX INHALATOR
K963755 · Spiracle Technology · Apr 1997
CPR BIO-BARRIER FACESHEILD
K960995 · O-Two Systems Intl., Inc. · Jan 1997