510(k) · Cleared
ClearedBioharness
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zephyr Technology Corporation · MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)
Cleared on Dec 3, 2010 as substantially equivalent to K061993 (Hidalgo Limited, 2006) and 3 other predicates after a 330-day review. Its family tree reaches back 6 generations to 1997. 3 later devices descend from it.
- Decided
- Dec 3, 2010
- Review
- 330 days
- Class
- Class II
- Product code
- MHX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 6 generations to K962603 (1997). 23 ancestors in all, the oldest K891104 (1989). 3 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 5 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
- 4 generations backK982255 Model 2000 Pulse OximeterIvy Biomedical Systems, Inc. · 1998
- 3 generations backK991823 N-395 Pulse Oximeter, Model N-395Nellcor Puritan Bennett, Inc. · 1999
- 2 generations backK012451 Propaq Encore Models 202, 204, 206; Propaq CS Models 242, 244, 246Welch Allyn Protocol, Inc. · 2001
- 1 generation backK061993 Equivital, Model EQ-01Hidalgo Limited · 2006
- This deviceK100040 BioharnessZephyr Technology Corporation · 2010
- Descendant · cites it directly · 2 of its ownK113045 BioharnessZephyr Technology Corporation · 2012
- Descendant · 2 generations on · 0 of its ownK171244 PhysiotraceNimbleheart, Inc. · 2017
- Descendant · 2 generations on · 0 of its ownK122763 Physiological Data ProcessorZephyr Technology Corporation · 2013
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables | Masimo Corp. | 1997 | — |
| −5 | K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables | Masimo Corp. | 1998 | — |
| −4 | K982255 | Model 2000 Pulse Oximeter | Ivy Biomedical Systems, Inc. | 1998 | — |
| −3 | K991823 | N-395 Pulse Oximeter, Model N-395 | Nellcor Puritan Bennett, Inc. | 1999 | — |
| −2 | K012451 | Propaq Encore Models 202, 204, 206; Propaq CS Models 242, 244, 246 | Welch Allyn Protocol, Inc. | 2001 | — |
| −1 | K061993 | Equivital, Model EQ-01 | Hidalgo Limited | 2006 | — |
| 0 (this device) | K100040 | Bioharness | Zephyr Technology Corporation | 2010 | — |
| +1 | K113045 | Bioharness | Zephyr Technology Corporation | 2012 | — |
| +2 | K171244 | Physiotrace | Nimbleheart, Inc. | 2017 | — |
| +2 | K122763 | Physiological Data Processor | Zephyr Technology Corporation | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2017 | 1 | 0 |
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 MHX? 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 MHX device
- #1 K251702 IntelliVue Patient Monitor MX750; IntelliVue…score 23.0 · 40 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K061993 | Equivital, Model EQ-01Summary page 2…RioHarness are the same as that of an existing legally marketed medical device manufactured by Hidalgo Ltd, the Equivital EQ-10 Vital Signs Physiological Monitor (K061993). Zephy r Technology Corporation is a developer and manufacturer of real-time monitoring solutions for defense, emergenc… | 2006 |
| * | K052489 | ActiheartSummary page 4…O Vital Signs Physiological Monitor (K061993). Additional predicate devices include: Respironics Actiheart K052489 VivoMetrics LifeShirt Real Time K043604 GMP IWireless Medicine… | 2005 |
| * | K043604 | Lifeshirt Real-Time with Vivomonitor SoftwareSummary page 4…Respironics Actiheart K052489 VivoMetrics LifeShirt Real Time K043604 GMP IWireless Medicine LifeSync K030795 A summary of similarities and differ… | 2005 |
| * | K030795 | Lifesyne SystemsSummary page 4…9 VivoMetrics LifeShirt Real Time K043604 GMP IWireless Medicine LifeSync K030795 A summary of similarities and differences between BioHarness and predicate devices are presented in the table below.… | 2003 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K113045 | Bioharness | 2012 | 2 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 6 companies; a new generation was cleared every 2.0 years on median.
- 3 of the 23 ancestors have a recall of any class.
- Of its descendants, K113045 (Zephyr Technology Corporation, 2012) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K061993.
How does its category compare?
All MHX devicesMHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms): FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · MHX
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MHX
192in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MHX
21so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MHX
3,761in 2025
MAUDE reports naming product code MHX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 15 | 96 | 3 | 131 |
| 2008 | 16 | 58 | 2 | 232 |
| 2009 | 13 | 57 | 7 | 382 |
| 2010 | 20 | 90 | 13 | 955 |
| 2011 | 12 | 81 | 16 | 949 |
| 2012 | 16 | 88 | 11 | 676 |
| 2013 | 21 | 120 | 14 | 1,997 |
| 2014 | 13 | 248 | 6 | 1,609 |
| 2015 | 14 | 203 | 5 | 1,284 |
| 2016 | 13 | 149 | 7 | 1,105 |
| 2017 | 14 | 134 | 6 | 1,115 |
| 2018 | 11 | 203 | 12 | 2,157 |
| 2019 | 7 | 243 | 6 | 1,462 |
| 2020 | 11 | 196 | 0 | 1,714 |
| 2021 | 5 | 195 | 0 | 2,423 |
| 2022 | 15 | 189 | 6 | 1,470 |
| 2023 | 8 | 229 | 3 | 2,254 |
| 2024 | 5 | 181 | 3 | 2,814 |
| 2025 | 8 | 192 | 15 | 3,761 |
| 2026 | 14 | 205 | 21 | — |
What is it indicated for?
The BioHarness is a physiological monitoring telemetry device intended for monitoring of adults in the home, workplace and alternate care settings. The device consists of a chest strap and an electronics module that attaches to the strap. The device stores and transmits vital sign data including heart rate, respiration rate, thoracic skin temperature, body orientation and activity. The RioHarness collects and transmits measurements captured during both…
Read the full statement (121 words)
The BioHarness is a physiological monitoring telemetry device intended for monitoring of adults in the home, workplace and alternate care settings. The device consists of a chest strap and an electronics module that attaches to the strap. The device stores and transmits vital sign data including heart rate, respiration rate, thoracic skin temperature, body orientation and activity.
The RioHarness collects and transmits measurements captured during both sedentary as well as rigorous activity for Heart Rate, Skin Temperature, Posture and Activity. Breathing rate values are accurately transmitted only during sedentary periods.
The RioHarness is indicated for use as a general patient monitor to provide physiological information as part of an occupational welfare monitoring system, and for general research and performance measurement purposes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100040 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100040: Bioharness.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100040
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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