Cleared Traditional

K895589 - MANUAL RESUSCITATOR

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

K895589 · Hudson Oxygen Therapy Sales Co. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

View all Hudson Oxygen Therapy Sales Co. devices

Submission Details

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
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.

Device Classification

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 33
Devices cleared under the same product code (BTM) and FDA review panel - the closest regulatory comparables to K895589.
SINGLE PATIENT USE INFANT DISPOSABLE MANUAL RESUSC
K903570 · Puritan Bennett Corp. · Aug 1990
INFANT MANUAL RESUSCITATOR (PMR 2)
K903631 · Puritan Bennett Corp. · Aug 1990
PURITAN BENNETT SINGLE PATIENT USE PEEP ADAPTER
K900349 · Puritan Bennett Corp. · May 1990
RESPIRONICS INFANT BAGEASY
K895351 · Respironics, Inc. · Oct 1989
SINGLE PATIENT USE DISPOSABLE MANUAL RESUSCITATOR
K894365 · Puritan Bennett Corp. · Oct 1989
STAT BLUE DISPOS. MANUAL RESUSCITATOR
K850436 · Vital Signs, Inc. · Feb 1985