510(k) · Cleared
Recalled · 2007Actical
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 22, 2006 as substantially equivalent to K983533 (Mini-Mitter Co., Inc., 1999) and 2 other predicates after a 171-day review. Its family tree reaches back 3 generations to 1991. 36 later devices descend from it. It has been recalled once.
- Decided
- Sep 22, 2006
- Review
- 171 days
- Class
- Class II
- Product code
- GWK
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 3 generations to K914085 (1991). 6 ancestors in all, the oldest K854030 (1986). 36 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK914085 HMS-5000Vitalog Monitoring,Inc. · 1991
- 2 generations backK991045 Mini-Logger Series 2000Mini-Mitter Co., Inc. · 1999
- 1 generation backK052489 ActiheartRespironics, Inc. · 2005
- This deviceK060919 ActicalRespironics, Inc. · 2006
- Descendant · cites it directly · 35 of its ownK122223 New: Intellivue CL Respiration Pod New: Specialized Assessory…Philips Medizin Systeme Boeblingen GmbH · 2013
- Descendant · 2 generations on · 24 of its ownK151736 Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boblingen GmbH · 2015
- Descendant · 3 generations on · 23 of its ownK161767 Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbH · 2017
- Descendant · 2 generations on · 20 of its ownK132320 Intellivue CL Respiration PodPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2014
- Descendant · 3 generations on · 19 of its ownK182543 Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap…Snap40, Ltd. · 2018
Showing 5 of 36 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 36 · See all- K122223New: Intellivue CL Respiration Pod New: Specialized Assessory: Mobile CL Resp Attachment…Philips Medizin Systeme Boeblingen GmbH · 2013 · cites it directly35descendants
- K151736Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boblingen GmbH · 2015 · 2 generations on24descendants
- K161767Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbH · 2017 · 3 generations on23descendants
- K132320Intellivue CL Respiration PodPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2014 · 2 generations on20descendants
- K182543Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple Device…Snap40, Ltd. · 2018 · 3 generations on19descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K914085 | HMS-5000 | Vitalog Monitoring,Inc. | 1991 | — |
| −2 | K991045 | Mini-Logger Series 2000 | Mini-Mitter Co., Inc. | 1999 | — |
| −1 | K052489 | Actiheart | Respironics, Inc. | 2005 | — |
| 0 (this device) | K060919 | Actical | Respironics, Inc. | 2006 | — |
| +1 | K122223 | New: Intellivue CL Respiration Pod New: Specialized Assessory: Mobile CL Resp… | Philips Medizin Systeme Boeblingen GmbH | 2013 | — |
| +2 | K151736 | Philips IntelliVue GuardianSoftware | Philips Medizin Systeme Boblingen GmbH | 2015 | — |
| +3 | K161767 | Philips IntelliVue GuardianSoftware | Philips Medizin Systeme Boeblingen GmbH | 2017 | — |
| +2 | K132320 | Intellivue CL Respiration Pod | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2014 | — |
| +3 | K182543 | Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple… | Snap40, Ltd. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 3 | 0 |
| 2021 | 2 | 0 |
| 2022 | 4 | 0 |
| 2023 | 4 | 0 |
| 2024 | 6 | 0 |
| 2025 | 6 | 0 |
| 2026 | 2 | 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? (3)
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 |
|---|---|---|---|
| * | K983533 | ActiwatchSummary page 1…Product Code: GWK §807.92 (a)(3) Legally Marketed Substantially Equivalent Device: Actiwatch® (K983533) Actiware-Sieep (K0l 1430) Actiheart (K052489) §80… | 1999 |
| * | K011430 | Actiware-PLMS | 2001 |
| * | K052489 | ActiheartSummary page 1…Actiwatch® (K983533) Actiware-Sieep (K0l 1430) Actiheart (K052489) §807.92 (a)(4) Description of Device: The subject device can be classified as physiological signal condition… | 2005 |
What descends from it? (36)
See all 361 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K122223 | New: Intellivue CL Respiration Pod New: Specialized Assessory: Mobile CL Resp Attachment… | 2013 | 35 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 27, 2007 | Not classified | Z-0325-2008 | Software design | Communication Failure: the devices have a memory chip that has a limited number of read/write cycles which can trigger set up information and/or subject information anomalies or intermittent communication annomalies. If left unaddressed… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 15 years and passes through 3 companies; a new generation was cleared every 6.0 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K122223 (Philips Medizin Systeme Boeblingen GmbH, 2013) has gone furthest, with 35 descendants of its own.
- 5 other devices also cite its predicate K983533.
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 Actical is a compact, lightweight, waist-, wrist-, or ankle-worn activity monitor that may be used to assess human gross motor activity, caloric expenditure, and estimates of energy expenditure based on motor activity in any instance where quantifiable analysis of physical motion is desirable.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060919 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060919: Actical.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060919
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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