Cleared Traditional

K915337 - CAPIOX LEVEL ALARM

K915337 is an FDA 510(k) clearance for CAPIOX LEVEL ALARM, manufactured by Terumo Medical Corp.. The device is a Class 2 Cardiovascular device with product code DTW cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K915337 · Terumo Medical Corp. · Cardiovascular device
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Feb 1992
Decision
87d
Days
Class 2
Risk

K915337 is an FDA 510(k) clearance for the CAPIOX LEVEL ALARM. Classified as Monitor And/or Control, Level Sensing, Cardiopulmonary Bypass (product code DTW), Class II - Special Controls.

Submitted by Terumo Medical Corp. (Elkton, US). The FDA issued a Cleared decision on February 21, 1992 after a review of 87 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 Terumo Medical Corp. devices

FDA 510(k) Submission Details - K915337

510(k) Number K915337 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 1991
Decision Date February 21, 1992
Days to Decision 87 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
38d faster than avg
Panel avg: 125d · This submission: 87d
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 9
Devices cleared under the same product code (DTW) and FDA review panel - the closest regulatory comparables to K915337.
Level Sensor, Level Sensor Tape
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