Cleared Traditional

K895589 - MANUAL RESUSCITATOR

K895589 is an FDA 510(k) clearance for MANUAL RESUSCITATOR, manufactured by Hudson Oxygen Therapy Sales Co.. The device is a Class 2 Anesthesiology device with product code BTM cleared through the Traditional 510(k) pathway after a 196-day FDA review.

K895589 · Hudson Oxygen Therapy Sales Co. · Anesthesiology device
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Mar 1990
Decision
196d
Days
Class 2
Risk

K895589 is an FDA 510(k) clearance for the MANUAL RESUSCITATOR. Classified as Ventilator, Emergency, Manual (resuscitator) (product code BTM), Class II - Special Controls.

Submitted by Hudson Oxygen Therapy Sales Co. (Temecula, US). The FDA issued a Cleared decision on March 30, 1990 after a review of 196 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5915 - 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.

FDA 510(k) Submission Details - K895589

510(k) Number K895589 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 1989
Decision Date March 30, 1990
Days to Decision 196 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
56d slower than avg
Panel avg: 140d · This submission: 196d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BTM Device Classification - Class 2, Special Controls

Product Code BTM Ventilator, Emergency, Manual (resuscitator)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5915
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 - BTM Ventilator, Emergency, Manual (resuscitator)

All 164
Devices cleared under the same product code (BTM) and FDA review panel - the closest regulatory comparables to K895589.
LIFE AID RESUSCITATOR
K901218 · Clarendon Supplies , Ltd. · May 1990
PURITAN BENNETT SINGLE PATIENT USE PEEP ADAPTER
K900349 · Puritan Bennett Corp. · May 1990
RESUSO MASK
K895820 · Rml Ent., Inc. · Apr 1990
ARTEC RESPOND PULMONARY RESUSCITATOR
K896886 · Artec Environmental Monitoring Division · Feb 1990
RESPIRONICS INFANT BAGEASY
K895351 · Respironics, Inc. · Oct 1989
MANUAL DISPOSABLE PULMONARY RESUSCITATOR
K895169 · F.L.W. Plastics, Inc. · Oct 1989
K895589 · MANUAL RESUSCITATOR
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