510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Terumobct, Inc.

Lakewood, CO, US

Terumobct, Inc. appears in FDA device records in Lakewood, CO. FDA records list 8 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.

FDA records held for this company

510(k) clearances
8
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

FDA records hold 8 510(k) clearances for Terumobct, Inc. between 2013 and 2019. The busiest year on record is 2013, with 2. The most recent is 2019, with 1.

Clearances by year, as a table
510(k) clearance decisions for Terumobct, Inc., by decision year
YearClearances
20132
20151
20161
20171
20182
20191
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K183081Spectra Optia Apheresis SystemLKNSubstantially Equivalent
K181049Spectra Optia Apheresis SystemLKNSubstantially Equivalent
K172590Spectra Optia Apheresis SystemLKNSubstantially Equivalent
K162365T-CuffKCYSubstantially Equivalent
K153601Spectra Optia Apheresis SystemLKNSubstantially Equivalent
K141938SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA EXCHANGE SET (DISPOSABLE BLOOD TUBING SET)LKNSubstantially Equivalent
K132429SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA SYSTEM SOFTWARE, SPECTRA OPTIA EXCHANGE DISPOSABLE SETLKNSubstantially Equivalent
K131744SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA SINGLE-NEEDLE CONNECTOR, SPECTRA OPTIA SYSTEM SOFTWARELKNSubstantially Equivalent

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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What MDM checks, and what it does not

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Data as of , FDA export datePage updated Source: openFDA, public domain