Cleared Traditional

K894365 - SINGLE PATIENT USE DISPOSABLE MANUAL RE...

K894365 is an FDA 510(k) clearance for SINGLE PATIENT USE DISPOSABLE MANUAL RE..., manufactured by Puritan Bennett Corp.. The device is a Class 2 Anesthesiology device with product code BTM cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K894365 · Puritan Bennett Corp. · Anesthesiology device
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Oct 1989
Decision
84d
Days
Class 2
Risk

K894365 is an FDA 510(k) clearance for the SINGLE PATIENT USE DISPOSABLE MANUAL RESUSCITATOR. Classified as Ventilator, Emergency, Manual (resuscitator) (product code BTM), Class II - Special Controls.

Submitted by Puritan Bennett Corp. (Overland Park, US). The FDA issued a Cleared decision on October 6, 1989 after a review of 84 days - a notably fast clearance 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: 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 Puritan Bennett Corp. devices

FDA 510(k) Submission Details - K894365

510(k) Number K894365 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 1989
Decision Date October 06, 1989
Days to Decision 84 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 faster than avg
Panel avg: 140d · This submission: 84d
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 82
Devices cleared under the same product code (BTM) and FDA review panel - the closest regulatory comparables to K894365.
PURITAN BENNETT SINGLE PATIENT USE PEEP ADAPTER
K900349 · Puritan Bennett Corp. · May 1990
MANUAL RESUSCITATOR
K895589 · Hudson Oxygen Therapy Sales Co. · Mar 1990
RESPIRONICS INFANT BAGEASY
K895351 · Respironics, Inc. · Oct 1989
PULMONARY RESUSCITATOR, MODIFICATION
K892221 · Life Design Systems, Inc. · May 1989
PULMANEX TM (NEO-NATAL SIZE)
K884068 · Life Design Systems, Inc. · Nov 1988
AMBU SPUR (SINGLE PATIENT USE RESUSCITATOR)
K883434 · Ambu, Inc. · Sep 1988