Cleared Traditional

K013421 - LIFEGUARD NASAL CPAP MASK AND ACCESSORIES

K013421 is an FDA 510(k) clearance for LIFEGUARD NASAL CPAP MASK AND ACCESSORIES, manufactured by Lifeguard Medical Products, Inc.. The device is a Class 2 Anesthesiology device with product code BZD cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K013421 · Lifeguard Medical Products, Inc. · Anesthesiology device
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Jan 2002
Decision
84d
Days
Class 2
Risk

K013421 is an FDA 510(k) clearance for the LIFEGUARD NASAL CPAP MASK AND ACCESSORIES. Classified as Ventilator, Non-continuous (respirator) (product code BZD), Class II - Special Controls.

Submitted by Lifeguard Medical Products, Inc. (Plainfield, US). The FDA issued a Cleared decision on January 8, 2002 after a review of 84 days - a notably fast clearance cycle.

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: 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 Lifeguard Medical Products, Inc. devices

FDA 510(k) Submission Details - K013421

510(k) Number K013421 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 16, 2001
Decision Date January 08, 2002
Days to Decision 84 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 140d · This submission: 84d
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 380
Devices cleared under the same product code (BZD) and FDA review panel - the closest regulatory comparables to K013421.
REMSTAR PRO WITH C-FLEX CPAP SYSTEM
K021861 · Respironics, Inc. · Jun 2002
ORION NASAL CPAP SYSTEM
K020730 · Bird Products Corp. · May 2002
REMSTAR AUTO CPAP SYSTEM
K012554 · Respironics, Inc. · Jan 2002
MINIME NASAL MASK, MODEL P/N 50220
K013306 · Sleepnet Corporation · Nov 2001
MODIFICATION TO: SIPAP INFANT NASAL CPAP CIRCUIT
K012034 · Sensor Medics Corp. · Jul 2001
BIPAP PRO BI-LEVEL SYSTEM
K011714 · Respironics, Inc. · Jun 2001