Cleared Traditional

K911856 - RESPIRONICS REMSTAR WITH REMOTE AND RAMP

K911856 is an FDA 510(k) clearance for RESPIRONICS REMSTAR WITH REMOTE AND RAMP, manufactured by Respironics, Inc.. The device is a Class 2 Anesthesiology device with product code BZD cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K911856 · Respironics, Inc. · Anesthesiology device
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Aug 1991
Decision
105d
Days
Class 2
Risk

K911856 is an FDA 510(k) clearance for the RESPIRONICS REMSTAR WITH REMOTE AND RAMP. 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 August 9, 1991 after a review of 105 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 Respironics, Inc. devices

FDA 510(k) Submission Details - K911856

510(k) Number K911856 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 1991
Decision Date August 09, 1991
Days to Decision 105 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
35d faster than avg
Panel avg: 140d · This submission: 105d
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 285
Devices cleared under the same product code (BZD) and FDA review panel - the closest regulatory comparables to K911856.
318A RESPIRATORY SUPPORT SYSTEM
K923590 · Puritan Bennett Corp. · Apr 1993
REMSTAR WTIH RAMP AND REMOTE MODIFICATION
K920699 · Respironics, Inc. · Dec 1992
INFANT/PEDIATRIC RESUSCITATION CIRCUIT W/APL
K911465 · Vital Signs, Inc. · Oct 1991
SALTER LABS INFANT NASAL CPAP CANNULA
K912434 · Salter Labs · Jul 1991
INFANT NASAL CANNULAE ASSEMBLY, MODIFIED
K911780 · Ackrad Laboratories · Jun 1991
MEDTRONIC SULLIVAN NASAL CPAP SYSTEM
K905404 · Medtronic Vascular · May 1991