Cleared Abbreviated

K102831 - RSI 4200

K102831 is an FDA 510(k) clearance for RSI 4200, manufactured by Reimers Systems, Inc.. The device is a Class 2 Anesthesiology device with product code CBF cleared through the Abbreviated 510(k) pathway after a 324-day FDA review.

K102831 · Reimers Systems, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2011
Decision
324d
Days
Class 2
Risk

K102831 is an FDA 510(k) clearance for the RSI 4200. Classified as Chamber, Hyperbaric (product code CBF), Class II - Special Controls.

Submitted by Reimers Systems, Inc. (Lorton, US). The FDA issued a Cleared decision on August 19, 2011 after a review of 324 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5470 - the FDA anesthesiology and respiratory device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Reimers Systems, Inc. devices

FDA 510(k) Submission Details - K102831

510(k) Number K102831 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2010
Decision Date August 19, 2011
Days to Decision 324 days
Submission Type Abbreviated
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
184d slower than avg
Panel avg: 140d · This submission: 324d
Pathway characteristics
Standards-based clearance path.

CBF Device Classification - Class 2, Special Controls

Product Code CBF Chamber, Hyperbaric
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5470
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 - CBF Chamber, Hyperbaric

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