Cleared Traditional

K844729 - RESUSCITATOR, PULMONARY, MANUAL

K844729 is an FDA 510(k) clearance for RESUSCITATOR, 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 111-day FDA review.

K844729 · Life Design Systems, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1985
Decision
111d
Days
Class 2
Risk

K844729 is an FDA 510(k) clearance for the RESUSCITATOR, PULMONARY, MANUAL. 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 March 25, 1985 after a review of 111 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Life Design Systems, Inc. devices

FDA 510(k) Submission Details - K844729

510(k) Number K844729 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 1984
Decision Date March 25, 1985
Days to Decision 111 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
29d faster than avg
Panel avg: 140d · This submission: 111d
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 K844729.
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
STAT BLUE DISPOS. MANUAL RESUSCITATOR
K850436 · Vital Signs, Inc. · Feb 1985
FLOW CONTROLLER
K843223 · Precision Medical, Inc. · Sep 1984
RESPIRONICS VENTEASY
K842693 · Respironics, Inc. · Aug 1984