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

Redwood City, CA, US

BIOINTELLISENSE INC. appears in FDA device records in Redwood City, CA. FDA records list 2 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show one recall for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
2
PMA records
0
Recall records
1
Registered establishments
2

510(k) clearance history

FDA records hold 2 510(k) clearances for Biointellisense Inc. between 2019 and 2024. The busiest year on record is 2019, with 1. The most recent is 2024, with 1.

Clearances by year, as a table
510(k) clearance decisions for Biointellisense Inc., by decision year
YearClearances
20191
20241
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K241101BioButton SystemDRGSubstantially Equivalent
K191614BioSticker SystemDRGSubstantially Equivalent

Registered establishments

FDA registered establishments for Biointellisense Inc., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30165926823016592682BIOINTELLISENSE INC.805 Veterans Blvd, Redwood City, CA 94063 US2026
30179860703017986070BIOINTELLISENSE INC.17301 W. Colfax Ave., Golden, CO 80401 US2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-2616-2024BioButton REF BIOST06040 with Software version 3.0.20 The BioButton System is a remote monitoring wearable device intended for continuous collection of physiological data in home and healthcare settings while the patient is at rest.Software anomaly causing the skin temperature measurement accuracy to be slightly out of specification.Class IIOpen, Classified

Verification record

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