510(k) · Cleared
ClearedPhysiotrace
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nimbleheart, Inc. · DRX Electrode, Electrocardiograph
Cleared on Aug 23, 2017 as substantially equivalent to K113045 (Zephyr Technology Corporation, 2012) after a 117-day review. Its family tree reaches back 8 generations to 1997.
- Decided
- Aug 23, 2017
- Review
- 117 days
- Class
- Class II
- Product code
- DRX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K962603 (1997). 35 ancestors in all, the oldest K863116 (1986). No later device cites it as a predicate yet.
- Root · 8 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 7 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
- 6 generations backK982255 Model 2000 Pulse OximeterIvy Biomedical Systems, Inc. · 1998
- 5 generations backK991823 N-395 Pulse Oximeter, Model N-395Nellcor Puritan Bennett, Inc. · 1999
- 4 generations backK012451 Propaq Encore Models 202, 204, 206; Propaq CS Models 242, 244, 246Welch Allyn Protocol, Inc. · 2001
- 3 generations backK061993 Equivital, Model EQ-01Hidalgo Limited · 2006
- 2 generations backK100040 BioharnessZephyr Technology Corporation · 2010
- 1 generation backK113045 BioharnessZephyr Technology Corporation · 2012
- This deviceK171244 PhysiotraceNimbleheart, Inc. · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables | Masimo Corp. | 1997 | — |
| −7 | K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables | Masimo Corp. | 1998 | — |
| −6 | K982255 | Model 2000 Pulse Oximeter | Ivy Biomedical Systems, Inc. | 1998 | — |
| −5 | K991823 | N-395 Pulse Oximeter, Model N-395 | Nellcor Puritan Bennett, Inc. | 1999 | — |
| −4 | K012451 | Propaq Encore Models 202, 204, 206; Propaq CS Models 242, 244, 246 | Welch Allyn Protocol, Inc. | 2001 | — |
| −3 | K061993 | Equivital, Model EQ-01 | Hidalgo Limited | 2006 | — |
| −2 | K100040 | Bioharness | Zephyr Technology Corporation | 2010 | — |
| −1 | K113045 | Bioharness | Zephyr Technology Corporation | 2012 | — |
| 0 (this device) | K171244 | Physiotrace | Nimbleheart, Inc. | 2017 | — |
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 |
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 DRX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K113045 | BioharnessSummary page 4…e Class: II Product Code: DRX, MWI CFR Section: 870.2360, 870.2300 Predicate Device: BioHarness 3.0 by Zephyr Technology Corporation K113045 Device Description The Physiotracetm Smart has a wearable and reusable design that can be wrapped and fastened around the torso… | 2012 |
What descends from it?
No later submission names this one as a predicate yet.
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 20 years and passes through 7 companies; a new generation was cleared every 2.0 years on median.
- 3 of the 35 ancestors have a recall of any class.
- 1 other device also cites its predicate K113045.
How does its category compare?
All DRX devicesDRX Electrode, Electrocardiograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · DRX
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · DRX
78in 2010
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DRX
6in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DRX
250in 2025
MAUDE reports naming product code DRX, 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 | 3 | 147 | 0 | 47 |
| 2008 | 3 | 17 | 0 | 15 |
| 2009 | 7 | 89 | 0 | 36 |
| 2010 | 5 | 78 | 4 | 48 |
| 2011 | 0 | — | 0 | 80 |
| 2012 | 0 | — | 0 | 41 |
| 2013 | 1 | — | 0 | 70 |
| 2014 | 1 | — | 0 | 27 |
| 2015 | 0 | — | 1 | 58 |
| 2016 | 0 | — | 0 | 37 |
| 2017 | 1 | — | 0 | 55 |
| 2018 | 0 | — | 0 | 43 |
| 2019 | 0 | — | 0 | 50 |
| 2020 | 0 | — | 5 | 53 |
| 2021 | 0 | — | 1 | 55 |
| 2022 | 0 | — | 6 | 61 |
| 2023 | 0 | — | 0 | 113 |
| 2024 | 0 | — | 0 | 61 |
| 2025 | 0 | — | 0 | 250 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Physiotracetm Smart is a telemetry device intended for physiological monitoring of men and women above 18 years of age at home, workplace, exercise facilities and alternate care settings. The Physiotracetm Smart records single lead ECG data for up to 60 minutes during resting and exercise activities; and transmits it to a server for review by healthcare team. The Physiotracetm Smart is indicated for use as a general patient monitor to provide…
Read the full statement (119 words)
The Physiotracetm Smart is a telemetry device intended for physiological monitoring of men and women above 18 years of age at home, workplace, exercise facilities and alternate care settings. The Physiotracetm Smart records single lead ECG data for up to 60 minutes during resting and exercise activities; and transmits it to a server for review by healthcare team. The Physiotracetm Smart 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.
The Physiotracetm Smart is not indicated for use on critical care patients. The Physiotrace Smart is not indicated for diagnosis of cardiac conditions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171244 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171244: Physiotrace.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171244
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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