Cleared Traditional

K992857 - LEVELSENS - FLEXIBLE, MODEL 201110, LEVELSENS - RIGID, MODEL 201070

K992857 is an FDA 510(k) clearance for LEVELSENS - FLEXIBLE, manufactured by Rocky Mountain Research, Inc.. The device is a Class 2 Cardiovascular device with product code DTW cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K992857 · Rocky Mountain Research, Inc. · Cardiovascular device
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Nov 1999
Decision
77d
Days
Class 2
Risk

K992857 is an FDA 510(k) clearance for the LEVELSENS - FLEXIBLE, MODEL 201110, LEVELSENS - RIGID, MODEL 201070. Classified as Monitor And/or Control, Level Sensing, Cardiopulmonary Bypass (product code DTW), Class II - Special Controls.

Submitted by Rocky Mountain Research, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on November 10, 1999 after a review of 77 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4340 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Rocky Mountain Research, Inc. devices

FDA 510(k) Submission Details - K992857

510(k) Number K992857 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 1999
Decision Date November 10, 1999
Days to Decision 77 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 125d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DTW Device Classification - Class 2, Special Controls

Product Code DTW Monitor And/or Control, Level Sensing, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4340
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - DTW Monitor And/or Control, Level Sensing, Cardiopulmonary Bypass

All 14
Devices cleared under the same product code (DTW) and FDA review panel - the closest regulatory comparables to K992857.
Level Sensor, Level Sensor Tape
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