Cleared Special

K150530 - Level Sensor, Level Sensor Tape

K150530 is an FDA 510(k) clearance for Level Sensor, manufactured by Medtronic, Inc.. The device is a Class 2 Cardiovascular device with product code DTW cleared through the Special 510(k) pathway after a 67-day FDA review.

K150530 · Medtronic, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2015
Decision
67d
Days
Class 2
Risk

K150530 is an FDA 510(k) clearance for the Level Sensor, Level Sensor Tape. Classified as Monitor And/or Control, Level Sensing, Cardiopulmonary Bypass (product code DTW), Class II - Special Controls.

Submitted by Medtronic, Inc. (Minneapolis, US). The FDA issued a Cleared decision on May 8, 2015 after a review of 67 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K150530

510(k) Number K150530 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 2015
Decision Date May 08, 2015
Days to Decision 67 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 125d · This submission: 67d
Pathway characteristics
Modification to existing cleared device.

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 K150530.
STOCKERTIR PURGE CONTROL (APC) SYSTEM
K041558 · Stockert Instrumente GmbH · Jul 2004
LEVELSENS - FLEXIBLE, MODEL 201110, LEVELSENS - RIGID, MODEL 201070
K992857 · Rocky Mountain Research, Inc. · Nov 1999
STOCKERT S3 UPS, LVL CTRL BUBB. DET., DUAL PRESS. CTRL., TEMP MONT., TIMER
K955152 · Stoeckert Instrumente · Feb 1996
STOCKERT CAPS LOW LEVEL DETECT II/BUBBLE MONITOR
K924354 · Sorin Biomedica, Fiat, USA, Inc. · Feb 1993
CAPIOX LEVEL ALARM
K915337 · Terumo Medical Corp. · Feb 1992
COBE AIR EMBOLI PROTECTION SYSTEM (AEPS)
K900910 · Cobe Laboratories, Inc. · May 1990
K150530 · Level Sensor, Level Sensor Tape
Download PDF FDA Summary Medtronic, Inc.