Cleared Traditional

K920699 - REMSTAR WTIH RAMP AND REMOTE MODIFICATION

K920699 is an FDA 510(k) clearance for REMSTAR WTIH RAMP AND REMOTE MODIFICATION, 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 313-day FDA review.

K920699 · Respironics, Inc. · Anesthesiology device
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Dec 1992
Decision
313d
Days
Class 2
Risk

K920699 is an FDA 510(k) clearance for the REMSTAR WTIH RAMP AND REMOTE MODIFICATION. Classified as Ventilator, Non-continuous (respirator) (product code BZD), Class II - Special Controls.

Submitted by Respironics, Inc. (Pittsburgh, US). The FDA issued a Cleared decision on December 7, 1992 after a review of 313 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 - K920699

510(k) Number K920699 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 1992
Decision Date December 07, 1992
Days to Decision 313 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
173d slower than avg
Panel avg: 140d · This submission: 313d
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 K920699.
NASAL/ORAL MASK
K925587 · Respironics, Inc. · Sep 1993
TOTAL FACE MASK
K925920 · Respironics, Inc. · Jul 1993
318A RESPIRATORY SUPPORT SYSTEM
K923590 · Puritan Bennett Corp. · Apr 1993
INFANT/PEDIATRIC RESUSCITATION CIRCUIT W/APL
K911465 · Vital Signs, Inc. · Oct 1991
RESPIRONICS REMSTAR WITH REMOTE AND RAMP
K911856 · Respironics, Inc. · Aug 1991
SALTER LABS INFANT NASAL CPAP CANNULA
K912434 · Salter Labs · Jul 1991