Cleared Traditional

K884068 - PULMANEX TM (NEO-NATAL SIZE)

K884068 is the FDA 510(k) clearance for PULMANEX TM (NEO-NATAL SIZE) by Life Design Systems, Inc.. It is a Class 2 Anesthesiology device (product code BTM) cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K884068 · Life Design Systems, Inc. · Anesthesiology device
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Nov 1988
Decision
78d
Days
Class 2
Risk

K884068 is an FDA 510(k) clearance for the PULMANEX TM (NEO-NATAL SIZE). Classified as Ventilator, Emergency, Manual (resuscitator) (product code BTM), Class II - Special Controls.

Submitted by Life Design Systems, Inc. (Franklin, US). The FDA issued a Cleared decision on November 16, 1988 after a review of 78 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 Life Design Systems, Inc. devices

Submission Details

510(k) Number K884068 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 1988
Decision Date November 16, 1988
Days to Decision 78 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 140d · This submission: 78d
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 K884068.
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
RESPIRONICS VENTEASY
K842693 · Respironics, Inc. · Aug 1984
CODE BLUE MANUAL RESUSCITATOR
K831885 · Vital Signs, Inc. · Sep 1983