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twiist Loop Algorithm (K262576): 510(k) cleared for Deka Research and Development Corp. vs Access BNP II (K262597): 510(k) cleared for Beckman Coulter, Inc.: FDAPulse comparison

Access BNP II (K262597): 510(k) cleared for Beckman Coulter, Inc.'s review days of 85 is 1.1x twiist Loop Algorithm (K262576): 510(k) cleared for Deka Research and Development Corp.'s 80 (25th percentile). twiist Loop Algorithm (K262576): 510(k) cleared for Deka Research and Development Corp. is dated 2026-10-15; Access BNP II (K262597): 510(k) cleared for Beckman Coulter, Inc. 2026-10-20.

Data as of · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)

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How does twiist Loop Algorithm (K262576): 510(k) cleared for Deka Research and Development Corp. compare to Access BNP II (K262597): 510(k) cleared for Beckman Coulter, Inc.?

Fieldtwiist Loop Algorithm (K262576): 510(k) cleared for Deka Research and Development Corp.Access BNP II (K262597): 510(k) cleared for Beckman Coulter, Inc.
Record510(k) clearance510(k) clearance
510(k) numberK262576K262597
Devicetwiist Loop AlgorithmAccess BNP II
ApplicantDeka Research and Development Corp.Beckman Coulter, Inc.
Specialty / panelClinical ChemistryClinical Chemistry
Product codeQJINBC
Device class22
Clearance typeTraditionalTraditional
DecisionSubstantially EquivalentSubstantially Equivalent
Received2026-07-272026-07-27
Decision date2026-10-152026-10-20
Review time (days)8085
Third-party reviewNoNo
Applicant locationManchester, NH, USChaska, MN, US
amount percentile23rd25th
Predicate Speed & CAPA Advisory Opportunity Score36/10036/100
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Official records: twiist Loop Algorithm (K262576): 510(k) cleared for Deka Research and Development Corp. · Access BNP II (K262597): 510(k) cleared for Beckman Coulter, Inc.

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Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.

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