Cleared Traditional

REMREST (K002763) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K002763 · Medical Industries America, Inc. · Anesthesiology device
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May 2001
Decision
241d
Days
Class 2
Risk

K002763 is an FDA 510(k) clearance for the REMREST. Classified as Ventilator, Non-continuous (respirator) (product code BZD), Class II - Special Controls.

Submitted by Medical Industries America, Inc. (Adel, US). The FDA issued a Cleared decision on May 4, 2001 after a review of 241 days - an extended review 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: 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 Medical Industries America, Inc. devices

Submission Details

510(k) Number K002763 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 05, 2000
Decision Date May 04, 2001
Days to Decision 241 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
101d slower than avg
Panel avg: 140d · This submission: 241d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 131
Devices cleared under the same product code (BZD) and FDA review panel - the closest regulatory comparables to K002763.
REMSTAR PRO WITH C-FLEX CPAP SYSTEM
K021861 · Respironics, Inc. · Jun 2002
REMSTAR AUTO CPAP SYSTEM
K012554 · Respironics, Inc. · Jan 2002
BIPAP PRO BI-LEVEL SYSTEM
K011714 · Respironics, Inc. · Jun 2001
REMSTAR PLUS CPAP SYSTEM
K010263 · Respironics, Inc. · Mar 2001
RESPIRONICS SILHOUETTE NASAL MASK, MODELS 1003224 AND 1003223
K000705 · Respironics, Inc. · Sep 2000
SPECTRUM 2 REUSABLE FULL FACE MASK, MODEL 1004884 AND 1004876
K002465 · Respironics, Inc. · Sep 2000