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 Aug 14, 2012 as substantially equivalent to K063044 (Monebo Technologies, Inc., 2007) and 1 other predicate after a 306-day review. Its family tree reaches back 7 generations to 1997. 2 later devices descend from it.
- Decided
- Aug 14, 2012
- Review
- 306 days
- Class
- Class II
- Product code
- MHX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K962603 (1997). 34 ancestors in all, the oldest K863116 (1986). 2 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 6 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
- 5 generations backK982255 Model 2000 Pulse OximeterIvy Biomedical Systems, Inc. · 1998
- 4 generations backK991823 N-395 Pulse Oximeter, Model N-395Nellcor Puritan Bennett, Inc. · 1999
- 3 generations backK012451 Propaq Encore Models 202, 204, 206; Propaq CS Models 242, 244, 246Welch Allyn Protocol, Inc. · 2001
- 2 generations backK061993 Equivital, Model EQ-01Hidalgo Limited · 2006
- 1 generation backK100040 BioharnessZephyr Technology Corporation · 2010
- This deviceK113045 BioharnessZephyr Technology Corporation · 2012
- Descendant · cites it directly · 0 of its ownK171244 PhysiotraceNimbleheart, Inc. · 2017
- Descendant · cites it directly · 0 of its ownK122763 Physiological Data ProcessorZephyr Technology Corporation · 2013
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables | Masimo Corp. | 1997 | — |
| −6 | K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables | Masimo Corp. | 1998 | — |
| −5 | K982255 | Model 2000 Pulse Oximeter | Ivy Biomedical Systems, Inc. | 1998 | — |
| −4 | K991823 | N-395 Pulse Oximeter, Model N-395 | Nellcor Puritan Bennett, Inc. | 1999 | — |
| −3 | K012451 | Propaq Encore Models 202, 204, 206; Propaq CS Models 242, 244, 246 | Welch Allyn Protocol, Inc. | 2001 | — |
| −2 | K061993 | Equivital, Model EQ-01 | Hidalgo Limited | 2006 | — |
| −1 | K100040 | Bioharness | Zephyr Technology Corporation | 2010 | — |
| 0 (this device) | K113045 | Bioharness | Zephyr Technology Corporation | 2012 | — |
| +1 | K171244 | Physiotrace | Nimbleheart, Inc. | 2017 | — |
| +1 | K122763 | Physiological Data Processor | Zephyr Technology Corporation | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 3 | 0 |
| 1997 | 1 | 0 |
| 1998 | 3 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 3 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (2)
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 |
|---|---|---|---|
| * | K063044 | Cardiobelt Electrode BeltSummary page 1…Cardiovascular Device Classification Class 11 Establishment registration No. # 233836 Predicate Device (1) Monebo, CardioBelt'ti, K063044, is a reusable electrode system consisting of an electrode assembly, an… | 2007 |
| * | K100040 | BioharnessSummary page 1…information to a compatible Bluetooth enabled device. (2) Zephyr Technology, RioHarness 2.0, K1 00040, is an ambulatory patient monitor consisting of a chest strap… | 2010 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 15 years and passes through 6 companies; a new generation was cleared every 1.7 years on median.
- 3 of the 34 ancestors have a recall of any class.
- Of its descendants, K171244 (Nimbleheart, Inc., 2017) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K063044.
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. 2012, 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 RioHarness 3.0 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 ECG, heart rate, respiration rate, body orientation and activity. The Biol-arness 3.0 provides a facility to detect and transmit single lead EGG signals to…
Read the full statement (150 words)
The RioHarness 3.0 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 ECG, heart rate, respiration rate, body orientation and activity. The Biol-arness 3.0 provides a facility to detect and transmit single lead EGG signals to be received by Bluetooth / USB qualified ECG instruments.
The RioHarness 3.0 collects and transmits measurements captured during both sedentary as well as rigorous activity for Heart Rate, Posture and Activity. Breathing rate values are accurately transmitted only during sedentary periods.
The RioHarness 3.0 is indicated for use as a general patient monitor to provide physiological information as part of an occupational welfare monitoring system, for general research and performance measurement purposes, or where prescribed by a healthcare professional.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113045 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113045: Bioharness.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113045
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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