Atlas FDA

Level Sensor, Level Sensor Tape

FDA 510(k) clearance K150530 · decided 2015-05-08

Clearance details

K-number
K150530
Device name
Level Sensor, Level Sensor Tape
Applicant
Medtronic, Inc.
Decision
Substantially Equivalent
Date received
2015-03-02
Decision date
2015-05-08
Days to decision
67 days
Clearance type
Special
Product code
DTW
Device class
2
Regulation number
870.4340
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Minneapolis, MN, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
STOCKERTIR PURGE CONTROL (APC) SYSTEM (K041558)Stockert Instrumente GmbH2004-07-02
LEVELSENS - FLEXIBLE, MODEL 201110, LEVELSENS - RIGID, MODEL 201070 (K992857)Rocky Mountain Research, Inc.1999-11-10
STOCKERT S3 UPS, LVL CTRL BUBB. DET., DUAL PRESS. CTRL., TEMP MONT., TIMER (K955152)Stoeckert Instrumente1996-02-22
CARDIOPULMONARY BYPASS LEVEL SENSING MONITOR (K910599)Jtl Medical Corp.1993-05-20
STOCKERT CAPS LOW LEVEL DETECT II/BUBBLE MONITOR (K924354)Sorin Biomedica, Fiat, USA, Inc.1993-02-18
CAPIOX LEVEL ALARM (K915337)Terumo Medical Corp.1992-02-21
COBE AIR EMBOLI PROTECTION SYSTEM (AEPS) (K900910)Cobe Laboratories, Inc.1990-05-22
SARNS 9000 PERFUSION SYSTEM W/ALERT ONLY LEVEL (K900815)3M Company1990-05-09
MYOCARDIAL TEMP. SENSOR W/TYPE T THERMOCOUPLE (K873206)Respiratory Support Products, Inc.1987-09-30
GAMBRO ULTRASONIC BLOOD LEVEL DETECTOR ULD 10-200 (K860076)Gambro, Inc.1986-05-30
SENSOR TAPE CAT. NO. ST-45 (K852407)American Omni Medical, Inc.1985-10-21
STOCKERT-SHILEY UNIVERSAL LEVEL SENSOR (K843802)Shiley, Inc.1984-12-27

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
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SynchroMed™ Infusion Systems (P860004/S453)Medtronic, Inc.2025-12-19
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Activa™ Deep Brain Stimulation Therapy System, Percept PC/RC BrainSense™ (P960009/S524)Medtronic, Inc.2025-12-08