Cleared Traditional

K883693 - RESUSCITATION BAG EXHALATION FILTER

K883693 is an FDA 510(k) clearance for RESUSCITATION BAG EXHALATION FILTER, manufactured by Intertech Resources, Inc.. The device is a Class 2 General Hospital device with product code CAH cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K883693 · Intertech Resources, Inc. · General Hospital
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Sep 1988
Decision
32d
Days
Class 2
Risk

K883693 is an FDA 510(k) clearance for the RESUSCITATION BAG EXHALATION FILTER. Classified as Filter, Bacterial, Breathing-circuit (product code CAH), Class II - Special Controls.

Submitted by Intertech Resources, Inc. (Fort Myers, US). The FDA issued a Cleared decision on September 30, 1988 after a review of 32 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 868.5260 - the FDA general hospital 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

FDA 510(k) Submission Details - K883693

510(k) Number K883693 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 1988
Decision Date September 30, 1988
Days to Decision 32 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
97d faster than avg
Panel avg: 129d · This submission: 32d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CAH Device Classification - Class 2, Special Controls

Product Code CAH Filter, Bacterial, Breathing-circuit
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5260
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 General Hospital devices follow this clearance model.

Regulatory Peers - CAH Filter, Bacterial, Breathing-circuit

All 74
Devices cleared under the same product code (CAH) and FDA review panel - the closest regulatory comparables to K883693.
CHILD SIZE - FILTER FLEX (TM)
K893030 · Life Design Systems, Inc. · Sep 1989
BACTERIA FILTER
K890035 · Hudson Oxygen Therapy Sales Co. · May 1989
OMNIFILTER MAIN FLOW BACTERIA FILTER
K890362 · Puritan Bennett Corp. · Mar 1989
SIEMENS MAIN FLOW BACTERIA FILTER
K871366 · Siemens Elema AB · May 1987
CURITY ANESTHESIA FILTER
K864103 · The Kendal Co. · Jan 1987
MP-1204 DISPOSABLE BACTERIA FILTER
K862785 · Medipart Jerry Alexander · Aug 1986