Cleared Traditional

K913714 - MODIFICATION MANUAL PULMON RESUSCITOR/PULMANEX(TM)

K913714 is an FDA 510(k) clearance for MODIFICATION MANUAL PULMON RESUSCITOR/P..., 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 474-day FDA review.

K913714 · Life Design Systems, Inc. · Anesthesiology device
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Dec 1992
Decision
474d
Days
Class 2
Risk

K913714 is an FDA 510(k) clearance for the MODIFICATION MANUAL PULMON RESUSCITOR/PULMANEX(TM). Classified as Ventilator, Emergency, Manual (resuscitator) (product code BTM), Class II - Special Controls.

Submitted by Life Design Systems, Inc. (Carrollton, US). The FDA issued a Cleared decision on December 1, 1992 after a review of 474 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Anesthesiology submissions.

View all Life Design Systems, Inc. devices

FDA 510(k) Submission Details - K913714

510(k) Number K913714 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 1991
Decision Date December 01, 1992
Days to Decision 474 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
334d slower than avg
Panel avg: 140d · This submission: 474d
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 K913714.
BAXTER ADULT/PEDI/INFANT SINGLE USE MAN RESUSCIT
K924610 · Engineered Medical Systems · Apr 1993
AID, CARDIOPULMONARY RESUSCITATION
K930429 · Valley Forge Scientific Corp. · Mar 1993
SPUR INFANT/CHILD W/O PRESSURE-LIMITING VALVE
K923762 · Ambu, Inc. · Feb 1993
LSPI INFANT BAG MASK
K921553 · Life Support Products, Inc. · Oct 1992
LSPI DISPOSABLE BAG MASK RESUSCITATOR/MODIFIED
K924217 · Life Support Products, Inc. · Sep 1992
AMBU SILICONE RESUSCITATOR, ADULT W/OPEN RESERVOIR
K924215 · Ambu, Inc. · Sep 1992