510(k) · Cleared
ClearedPhilips wearable biosensor-G5 Solution
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Connected Sensing- A Division of Philips Medical Systems · DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
Cleared on Mar 7, 2019 as substantially equivalent to K123658 (Zephyr Technology Corporation, 2013) after a 309-day review. Its family tree reaches back 1 generation to 2013. 1 later device descends from it.
- Decided
- Mar 7, 2019
- Review
- 309 days
- Class
- Class II
- Product code
- DRT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K123658 (2013). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK123658 Biomodule 3-M1Zephyr Technology Corporation · 2013
- This deviceK181165 Philips wearable biosensor-G5 SolutionConnected Sensing- A Division of Philips Medical Systems · 2019
- Descendant · cites it directly · 0 of its ownK192875 Philips Biosensor BX100Philips Medical Systems · 2020
Most influential descendants
Showing 1 of 1 · See all- K192875Philips Biosensor BX100Philips Medical Systems · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K123658 | Biomodule 3-M1 | Zephyr Technology Corporation | 2013 | — |
| 0 (this device) | K181165 | Philips wearable biosensor-G5 Solution | Connected Sensing- A Division of Philips Medical Systems | 2019 | — |
| +1 | K192875 | Philips Biosensor BX100 | Philips Medical Systems | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 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 DRT? 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 DRT device
- #1 K252676 The Circadia C300 System (C300)score 15.3 · 6 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 |
|---|---|---|---|
| * | K123658 | Biomodule 3-M1Summary page 4…ication Name: Monitor, Cardiac (Incl. Cardiotachometer and rate alarm) (21 CFR 870.2300) Regulatory Class: II Product Code: DRT III. PREDICATE DEVICE BioModule 3-MI, K123658 This predicate has not been subject to a design-related recall. No reference devices were used in this submission. IV. DEVIC… | 2013 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K192875 | Philips Biosensor BX100 | 2020 | 0 |
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?
How does its category compare?
All DRT devicesDRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm): FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · DRT
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DRT
228in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DRT
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DRT
40in 2025
MAUDE reports naming product code DRT, 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 | 1 | — | 0 | 113 |
| 2008 | 1 | — | 0 | 99 |
| 2009 | 6 | 70 | 0 | 118 |
| 2010 | 3 | 44 | 0 | 63 |
| 2011 | 3 | 149 | 1 | 36 |
| 2012 | 1 | — | 0 | 47 |
| 2013 | 1 | — | 0 | 16 |
| 2014 | 0 | — | 0 | 26 |
| 2015 | 1 | — | 0 | 48 |
| 2016 | 1 | — | 0 | 55 |
| 2017 | 1 | — | 0 | 159 |
| 2018 | 1 | — | 0 | 224 |
| 2019 | 1 | — | 0 | 447 |
| 2020 | 0 | — | 0 | 50 |
| 2021 | 2 | — | 1 | 85 |
| 2022 | 1 | — | 0 | 35 |
| 2023 | 1 | — | 0 | 47 |
| 2024 | 3 | 228 | 1 | 29 |
| 2025 | 1 | — | 0 | 40 |
| 2026 | 5 | 120 | 0 | — |
What is it indicated for?
The Philips wearable biosensor-G5 is indicated for single patient use whenever heart rate measurement is needed in non-critical hospital settings. The Philips wearable biosensor-G5 solution is used as a higher resolution heart rate log by nurses or physicians retrospectively as an aid in making non-critical or non-life threatening therapeutic decisions. The biosensor is intended for patients who are 18 years of age or older.
The G5 Biosensor is intended only for patients with a baseline narrow QRS complex (less than 100 ms).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181165 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181165: Philips wearable biosensor-G5 Solution.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181165
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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