510(k) Report

510(k) · Cleared

Recalled · Class II · 2024

BioButton System

K212957510(k) TraditionalCleared Dec 12, 2022452-day reviewClass II21 CFR 870.2910Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Biolntellisense, Inc. · DRG Transmitters And Receivers, Physiological Signal, Radiofrequency

Cleared on Dec 12, 2022 as substantially equivalent to K191614 (Biointellisense, Inc., 2019) after a 452-day review. Its family tree reaches back 1 generation to 2019. 1 later device descends from it. It has been recalled once.

Decided
Dec 12, 2022
Review
452 days
Class
Class II
Product code
DRG
Recalls
1
Predicates
1

Its longest line of descent runs back 1 generation to K191614 (2019). 1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2024: 1 descendant clearedK191614 · BioSticker System · Biointellisense, Inc. · 2019201620182020202220242026
Descendants, by generation 1 generation forward: 1 descendant K191614 · BioSticker System · Biointellisense, Inc. · 20190
  1. Root · 1 generation backK191614 BioSticker SystemBiointellisense, Inc. · 2019
  2. This deviceK212957 BioButton SystemBiolntellisense, Inc. · 2022
  3. Descendant · cites it directly · 0 of its ownK241101 BioButton SystemBiointellisense, Inc. · 2024

Most influential descendants

Showing 1 of 1 · See all
  • K241101BioButton SystemBiointellisense, Inc. · 2024 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K191614BioSticker SystemBiointellisense, Inc.2019—
0 (this device)K212957BioButton SystemBiolntellisense, Inc.2022—
+1K241101BioButton SystemBiointellisense, Inc.2024—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202410
FIG. 1 — Lineage of K212957, 2019–2024Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in DRG? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new DRG device

  1. #1 K223711 ANNE Onescore 20.8 · 11 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K191614BioSticker System
Summary page 5
…icate Device BioIntelliSense Inc. Manufacturer Predicate Device Trade BioSticker System Name Predicate Device 510(k) K191614 Number IV. Device Description The BioButton System is a wireless remote monitoring system intended for use by healthcare…
Biointellisense, Inc.2019—

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K241101BioButton SystemBiointellisense, Inc.20240

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Jul 19, 2024Class IIZ-2616-2024Device DesignSoftware anomaly causing the skin temperature measurement accuracy to be slightly out of specification.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has no recall.
  • Of its descendants, K241101 (Biointellisense, Inc., 2024) has gone furthest, with 0 descendants of its own.

How does its category compare?

All DRG devices

DRG Transmitters And Receivers, Physiological Signal, Radiofrequency: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.

FDA decisions per year · DRG

3in 2025

2007: 62008: 52009: 132010: 102011: 92012: 122013: 132014: 102015: 22016: 22017: 72018: 62019: 52020: 62021: 22022: 62023: 42024: 32025: 32026 (partial year): 2
2007high 13 (2009) · low 2 (2015)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DRG

127in 2025

2007: 63 days median2008: 74 days median2009: 94 days median2010: 68 days median2011: 104 days median2012: 103 days median2013: 146 days median2014: 177 days median2017: 98 days median2018: 220 days median2019: 122 days median2020: 159 days median2022: 287 days median2023: 212 days median2024: 125 days median2025: 127 days median
2007high 287 (2022) · low 63 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DRG

3in 2007

2007: 32026 (partial year): 1
2007high 3 (2007) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DRG

52in 2025

2007: 142008: 92009: 52010: 132011: 122012: 92013: 132014: 972015: 1312016: 1822017: 4842018: 1662019: 702020: 822021: 1072022: 432023: 192024: 262025: 52
2007high 484 (2017) · low 5 (2009)2025

MAUDE reports naming product code DRG, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007663314
200857409
2009139405
20101068013
20119104012
20121210309
201313146013
201410177097
20152—0131
20162—0182
20177980484
201862200166
20195122070
20206159082
20212—0107
20226287043
20234212019
20243125026
20253127052
20262—1—

What is it indicated for?

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. This could include heart rate, respiratory rate, skin temperature, and other data such as activity level, body position, sleep, and step and gait analysis. Data are securely transmitted via wireless connection from the device for storage, review, and further analysis. The data…

Read the full statement (125 words)

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. This could include heart rate, respiratory rate, skin temperature,

and other data such as activity level, body position, sleep, and step and gait analysis.

Data are securely transmitted via wireless connection from the device for storage, review, and further analysis.

The data from the device are intended as an aid to diagnosis, diseases management, and treatment.

The device is intended for use on users who are 18 years of age or older.

The device is not intended to output physiological measurements while the user undergoes significant motion or is active.

The device is not intended for critical care.

Indications for use as stated in the FDA summary.

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https://510kreport.com/device/K212957 · printed Nov 6, 2026

Cite this page

510(k) Report. “K212957: BioButton System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212957

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026