Cleared Traditional

K863026 - PULMANEX TM (MODIFICATION)

K863026 is an FDA 510(k) clearance for PULMANEX TM (MODIFICATION), manufactured by Life Design Systems, Inc.. The device is a Class 2 Anesthesiology device with product code BTM cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K863026 · Life Design Systems, Inc. · Anesthesiology device
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Aug 1986
Decision
15d
Days
Class 2
Risk

K863026 is an FDA 510(k) clearance for the PULMANEX TM (MODIFICATION). Classified as Ventilator, Emergency, Manual (resuscitator) (product code BTM), Class II - Special Controls.

Submitted by Life Design Systems, Inc. (Milwaukee, US). The FDA issued a Cleared decision on August 26, 1986 after a review of 15 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

FDA 510(k) Submission Details - K863026

510(k) Number K863026 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 1986
Decision Date August 26, 1986
Days to Decision 15 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
125d faster than avg
Panel avg: 140d · This submission: 15d
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 106
Devices cleared under the same product code (BTM) and FDA review panel - the closest regulatory comparables to K863026.
NONREBREATHING CIRCUIT
K882285 · Dryden Corp. · Aug 1988
LSP DISPOSABLE BAG RESUSCITATOR, MODEL 470
K874418 · Life Support Products, Inc. · Jan 1988
DISPOSABLE, MANUAL PULMONARY RESUSCITATOR
K873286 · Hospitak, Inc. · Oct 1987
PULMANEX (TM)
K860693 · Life Design Systems, Inc. · Mar 1986
MODEL 446 & 447 MOUTH TO MASK RESUSCITATOR
K860180 · Life Support Products, Inc. · Mar 1986
PULMANEX
K854037 · Life Design Systems, Inc. · Nov 1985