Cleared Traditional

K862448 - FLOW GENERATOR FOR SLEEP APNEA, LDS 1500

K862448 is an FDA 510(k) clearance for FLOW GENERATOR FOR SLEEP APNEA, manufactured by Life Design Systems, Inc.. The device is a Class 2 Anesthesiology device with product code BZD cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K862448 · Life Design Systems, Inc. · Anesthesiology device
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Nov 1986
Decision
140d
Days
Class 2
Risk

K862448 is an FDA 510(k) clearance for the FLOW GENERATOR FOR SLEEP APNEA, LDS 1500. Classified as Ventilator, Non-continuous (respirator) (product code BZD), Class II - Special Controls.

Submitted by Life Design Systems, Inc. (Milwaukee, US). The FDA issued a Cleared decision on November 14, 1986 after a review of 140 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5905 - 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 - K862448

510(k) Number K862448 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 1986
Decision Date November 14, 1986
Days to Decision 140 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
At panel average
Panel avg: 140d · This submission: 140d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BZD Device Classification - Class 2, Special Controls

Product Code BZD Ventilator, Non-continuous (respirator)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5905
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 - BZD Ventilator, Non-continuous (respirator)

All 318
Devices cleared under the same product code (BZD) and FDA review panel - the closest regulatory comparables to K862448.
H-H HARRIS NEONATAL NASAL CANNULA SET FOR CPAP
K871351 · Holter-Hausner Intl. · May 1987
C.P.A.P. NASAL CANNULA
K871157 · Hudson Oxygen Therapy Sales Co. · Apr 1987
BIRD NIGHTBIRD NASAL CPAP SYSTEM
K863746 · Bird Products Corp. · Dec 1986
CIRCAPAK UNIVERSAL VOLUME VENTILATOR CIRCUIT
K861555 · Respiratory Care, Inc. · Jun 1986
MEDICOMP CPAP NASAL CANNULA
K861280 · Medicomp, Inc. · May 1986
PATIENT BREATHING CIRCUIT
K853487 · Infrasonics Corp. · Sep 1985