Cleared Traditional

K832697 - RMP INTUBATION EQUIP. STORAGE TRAY

K832697 is an FDA 510(k) clearance for RMP INTUBATION EQUIP. STORAGE TRAY, manufactured by Rmp Co.. The device is a Class 1 Anesthesiology device with product code BZN cleared through the Traditional 510(k) pathway after a 139-day FDA review.

K832697 · Rmp Co. · Anesthesiology device
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Dec 1983
Decision
139d
Days
Class 1
Risk

K832697 is an FDA 510(k) clearance for the RMP INTUBATION EQUIP. STORAGE TRAY. Classified as Cart, Emergency, Cardiopulmonary (excluding Equipment) (product code BZN), Class I - General Controls.

Submitted by Rmp Co. (Mchenry, US). The FDA issued a Cleared decision on December 27, 1983 after a review of 139 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.6175 - 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 Rmp Co. devices

FDA 510(k) Submission Details - K832697

510(k) Number K832697 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 1983
Decision Date December 27, 1983
Days to Decision 139 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
1d faster than avg
Panel avg: 140d · This submission: 139d
Pathway characteristics
Predicate-based equivalence.

BZN Device Classification - Class 1, General Controls

Product Code BZN Cart, Emergency, Cardiopulmonary (excluding Equipment)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.6175
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.