Cleared Special

K011714 - BIPAP PRO BI-LEVEL SYSTEM

K011714 is an FDA 510(k) clearance for BIPAP PRO BI-LEVEL SYSTEM, manufactured by Respironics, Inc.. The device is a Class 2 Anesthesiology device with product code BZD cleared through the Special 510(k) pathway after a 24-day FDA review.

K011714 · Respironics, Inc. · Anesthesiology device
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Jun 2001
Decision
24d
Days
Class 2
Risk

K011714 is an FDA 510(k) clearance for the BIPAP PRO BI-LEVEL SYSTEM. Classified as Ventilator, Non-continuous (respirator) (product code BZD), Class II - Special Controls.

Submitted by Respironics, Inc. (Murrysville, US). The FDA issued a Cleared decision on June 28, 2001 after a review of 24 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Respironics, Inc. devices

FDA 510(k) Submission Details - K011714

510(k) Number K011714 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 2001
Decision Date June 28, 2001
Days to Decision 24 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
116d faster than avg
Panel avg: 140d · This submission: 24d
Pathway characteristics
Modification to existing cleared device.

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 285
Devices cleared under the same product code (BZD) and FDA review panel - the closest regulatory comparables to K011714.
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
ORACLE ORAL MASK
K003894 · Fisher &Paykel Healthcare , Ltd. · Jun 2001
REMSTAR PLUS CPAP SYSTEM
K010263 · Respironics, Inc. · Mar 2001
RESPIRONICS SILHOUETTE NASAL MASK, MODELS 1003224 AND 1003223
K000705 · Respironics, Inc. · Sep 2000