Cleared Traditional

K854037 - PULMANEX

K854037 is an FDA 510(k) clearance for PULMANEX, 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 51-day FDA review.

K854037 · Life Design Systems, Inc. · Anesthesiology device
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Nov 1985
Decision
51d
Days
Class 2
Risk

K854037 is an FDA 510(k) clearance for the PULMANEX. 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 November 1, 1985 after a review of 51 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 - K854037

510(k) Number K854037 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 1985
Decision Date November 01, 1985
Days to Decision 51 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
89d faster than avg
Panel avg: 140d · This submission: 51d
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 K854037.
PULMANEX TM (MODIFICATION)
K863026 · Life Design Systems, Inc. · Aug 1986
PULMANEX (TM)
K860693 · Life Design Systems, Inc. · Mar 1986
MODEL 446 & 447 MOUTH TO MASK RESUSCITATOR
K860180 · Life Support Products, Inc. · Mar 1986
RESUSCITATOR, PULMONARY, MANUAL
K844729 · Life Design Systems, Inc. · Mar 1985
STAT BLUE DISPOS. MANUAL RESUSCITATOR
K850436 · Vital Signs, Inc. · Feb 1985
FLOW CONTROLLER
K843223 · Precision Medical, Inc. · Sep 1984