510(k) · Cleared
ClearedActiheart
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Respironics, Inc. · GWK Conditioner, Signal, Physiological
Cleared on Sep 27, 2005 as substantially equivalent to K991045 (Mini-Mitter Co., Inc., 1999) after a 15-day review. Its family tree reaches back 2 generations to 1991. 132 later devices descend from it.
- Decided
- Sep 27, 2005
- Review
- 15 days
- Class
- Class II
- Product code
- GWK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K914085 (1991). 132 later devices descend from it, 6 citing it directly.
- Root · 2 generations backK914085 HMS-5000Vitalog Monitoring,Inc. · 1991
- 1 generation backK991045 Mini-Logger Series 2000Mini-Mitter Co., Inc. · 1999
- This deviceK052489 ActiheartRespironics, Inc. · 2005
- Descendant · cites it directly · 99 of its ownK061993 Equivital, Model EQ-01Hidalgo Limited · 2006
- Descendant · cites it directly · 71 of its ownK113054 EquivitalHidalgo Limited · 2012
- Descendant · 2 generations on · 70 of its ownK141167 Vitalconnect Platform (Consisting of Vitalconnect Sensor, Relay…Vitalconnect, Inc. · 2014
- Descendant · 3 generations on · 43 of its ownK152139 Vital Connect Platform, HealthPatch MD, VitalPatchVitalconnect, Inc. · 2015
- Descendant · cites it directly · 36 of its ownK060919 ActicalRespironics, Inc. · 2006 · Recalled
Showing 5 of 132 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 132 · See all- K061993Equivital, Model EQ-01Hidalgo Limited · 2006 · cites it directly99descendants
- K113054EquivitalHidalgo Limited · 2012 · cites it directly71descendants
- K141167Vitalconnect Platform (Consisting of Vitalconnect Sensor, Relay Software Library and…Vitalconnect, Inc. · 2014 · 2 generations on70descendants
- K152139Vital Connect Platform, HealthPatch MD, VitalPatchVitalconnect, Inc. · 2015 · 3 generations on43descendants
- K060919ActicalRespironics, Inc. · 2006 · cites it directly36descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K914085 | HMS-5000 | Vitalog Monitoring,Inc. | 1991 | — |
| −1 | K991045 | Mini-Logger Series 2000 | Mini-Mitter Co., Inc. | 1999 | — |
| 0 (this device) | K052489 | Actiheart | Respironics, Inc. | 2005 | — |
| +1 | K061993 | Equivital, Model EQ-01 | Hidalgo Limited | 2006 | — |
| +1 | K113054 | Equivital | Hidalgo Limited | 2012 | — |
| +2 | K141167 | Vitalconnect Platform (Consisting of Vitalconnect Sensor, Relay Software… | Vitalconnect, Inc. | 2014 | — |
| +3 | K152139 | Vital Connect Platform, HealthPatch MD, VitalPatch | Vitalconnect, Inc. | 2015 | — |
| +1 | K060919 | Actical | Respironics, Inc. | 2006 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 3 | 0 |
| 2008 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 5 | 0 |
| 2014 | 4 | 0 |
| 2015 | 6 | 0 |
| 2016 | 4 | 0 |
| 2017 | 6 | 0 |
| 2018 | 7 | 0 |
| 2019 | 10 | 0 |
| 2020 | 10 | 0 |
| 2021 | 5 | 0 |
| 2022 | 10 | 0 |
| 2023 | 15 | 0 |
| 2024 | 13 | 0 |
| 2025 | 19 | 0 |
| 2026 | 8 | 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 GWK? 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 |
|---|---|---|---|
| * | K991045 | Mini-Logger Series 2000Summary page 2…ary Substantial Equivalence This premarket notification submission demonstrates that the Actiheart system is substantially equivalent to the Mini Logger Series 2000 (K991045). The design of the Actiheart was verified through the use of design verification and validation testing. The Hazards Control Me… | 1999 |
What descends from it? (132)
See all 1326 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 14 years and passes through 3 companies; a new generation was cleared every 7.8 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K061993 (Hidalgo Limited, 2006) has gone furthest, with 99 descendants of its own.
- 1 other device also cites its predicate K991045.
How does its category compare?
All GWK devicesGWK Conditioner, Signal, Physiological: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GWK
FDA has decided no GWK device since 2007.
Median 510(k) review, days · GWK
Too few GWK 510(k)s in any year since 2007 to give a median.
Recalls per year · GWK
No recall names GWK since 2007.
Adverse event reports per year · GWK
1in 2013
MAUDE reports naming product code GWK, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Actiheart is an ambulatory Heart Rate and Activity Recorder. Actiheart may be used to quantifiably measure Heart Rate, Activity, and estimates of Caloric Expenditure. This device is not intended for use as an ECG monitor.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052489 · printed Nov 4, 2026
Cite this page
510(k) Report. “K052489: Actiheart.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K052489
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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