510(k) · Cleared
ClearedDCM (PW-DCM)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pneumowave, Ltd. · LEL Device, Sleep Assessment
Cleared on Apr 16, 2025 as substantially equivalent to K231532 (Actigraph, LLC, 2023) after a 155-day review. Its family tree reaches back 7 generations to 1986.
- Decided
- Apr 16, 2025
- Review
- 155 days
- Class
- Class II
- Product code
- LEL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K854030 (1986). No later device cites it as a predicate yet.
- Root · 7 generations backK854030 Wrist ActigraphAmbulatory Monitoring, Inc. · 1986
- 6 generations backK983533 ActiwatchMini-Mitter Co., Inc. · 1999 · Recalled
- 5 generations backK992410 ActitracIndividual Monitoring Systems, Inc. · 1999
- 4 generations backK040554 Actigraph, Model AM7164-2.2 and Actigraph with Extended Memory…Manufacturing Technology, Inc. · 2004
- 3 generations backK080545 ActitrainerActigraph, LLC · 2008
- 2 generations backK181077 ActiGraph CentrePoint Insight WatchActigraph · 2018
- 1 generation backK231532 ActiGraph LEAP activity monitor (ActiGraph LEAP)Actigraph, LLC · 2023
- This deviceK243513 DCM (PW-DCM)Pneumowave, Ltd. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K854030 | Wrist Actigraph | Ambulatory Monitoring, Inc. | 1986 | — |
| −6 | K983533 | Actiwatch | Mini-Mitter Co., Inc. | 1999 | 3 |
| −5 | K992410 | Actitrac | Individual Monitoring Systems, Inc. | 1999 | — |
| −4 | K040554 | Actigraph, Model AM7164-2.2 and Actigraph with Extended Memory, Model AM71256 | Manufacturing Technology, Inc. | 2004 | — |
| −3 | K080545 | Actitrainer | Actigraph, LLC | 2008 | — |
| −2 | K181077 | ActiGraph CentrePoint Insight Watch | Actigraph | 2018 | — |
| −1 | K231532 | ActiGraph LEAP activity monitor (ActiGraph LEAP) | Actigraph, LLC | 2023 | — |
| 0 (this device) | K243513 | DCM (PW-DCM) | Pneumowave, Ltd. | 2025 | — |
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 LEL? 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 LEL device
- #1 K252981 EmbraceMiniscore 23.3 · 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? (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 |
|---|---|---|---|
| * | K231532 | ActiGraph LEAP activity monitor (ActiGraph LEAP)Summary page 5…ce Classification Name: Biofeedback Device Classification Codes: LEL Regulation Number: 21 CFR §882.5050 Predicate Devices: Actigraph LEAP (K231532) Actigraph, LLC Indications for Use: DCM is a small worn activity monitor designed for documenting physical movement as… | 2023 |
| † | K132764 | Motion Watch and Pro-Diary | 2014 |
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 39 years and passes through 7 companies; a new generation was cleared every 4.8 years on median.
- 1 of the 7 ancestors has a recall of any class.
How does its category compare?
All LEL devicesLEL Device, Sleep Assessment: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · LEL
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LEL
96in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LEL
No recall names LEL since 2007.
Adverse event reports per year · LEL
1in 2021
MAUDE reports naming product code LEL, 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 | 1 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 3 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 2 | — | 0 | 0 |
| 2025 | 3 | 96 | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
DCM is a small worn activity monitor designed for documenting physical movement associated with applications in physiological monitoring.
The device is intended to monitor the activity associated with movement during sleep.
DCM can be used to analyze circadian rhythms and assess activity in any instance where quantifiable analysis of physical motion is desirable.
DCM is indicated for monitoring of adult patients only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K243513 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243513: DCM (PW-DCM).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243513
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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