510(k) · Cleared
ClearedZoe Medical Nightingale Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zoe Medical, Inc. · DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
Cleared on Jan 12, 2001 after a 214-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 14 later devices descend from it.
- Decided
- Jan 12, 2001
- Review
- 214 days
- Class
- Class II
- Product code
- DRT
- Recalls
- None
- Predicates
- 0
14 later devices descend from it, 3 citing it directly.
- This deviceK001775 Zoe Medical Nightingale Monitoring SystemZoe Medical, Inc. · 2001
- Descendant · cites it directly · 11 of its ownK062144 Escort M8 Vital Signs Patient Monitor, Model 3810Invivo Corporation · 2006
- Descendant · cites it directly · 10 of its ownK090556 Spacelabs Elance Vital Signs Monitoring System and Central Monitor…Spacelabs Healthcare Medical Equipment (Suzhou) CO · 2009 · Recalled
- Descendant · 2 generations on · 3 of its ownK130740 Nightingale Monitoring SystemZoe Medical, Inc. · 2013
- Descendant · 2 generations on · 2 of its ownK123556 Mortara Surveyor Patient MonitorMortara Instrument, Inc. · 2013 · Recalled
- Descendant · 3 generations on · 1 of its ownK161517 Mortara Surveyor Patient MonitorMortara Instrument, Inc. · 2017
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K062144Escort M8 Vital Signs Patient Monitor, Model 3810Invivo Corporation · 2006 · cites it directly11descendants
- K090556Spacelabs Elance Vital Signs Monitoring System and Central Monitor SoftwareSpacelabs Healthcare Medical Equipment (Suzhou) CO · 2009 · cites it directly10descendants
- K130740Nightingale Monitoring SystemZoe Medical, Inc. · 2013 · 2 generations on3descendants
- K123556Mortara Surveyor Patient MonitorMortara Instrument, Inc. · 2013 · 2 generations on2descendants
- K161517Mortara Surveyor Patient MonitorMortara Instrument, Inc. · 2017 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K001775 | Zoe Medical Nightingale Monitoring System | Zoe Medical, Inc. | 2001 | — |
| +1 | K062144 | Escort M8 Vital Signs Patient Monitor, Model 3810 | Invivo Corporation | 2006 | — |
| +1 | K090556 | Spacelabs Elance Vital Signs Monitoring System and Central Monitor Software | Spacelabs Healthcare Medical Equipment (Suzhou) CO | 2009 | 1 |
| +2 | K130740 | Nightingale Monitoring System | Zoe Medical, Inc. | 2013 | — |
| +2 | K123556 | Mortara Surveyor Patient Monitor | Mortara Instrument, Inc. | 2013 | 1 |
| +3 | K161517 | Mortara Surveyor Patient Monitor | Mortara Instrument, Inc. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2013 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (14)
See all 143 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?
- Of its descendants, K062144 (Invivo Corporation, 2006) has gone furthest, with 11 descendants of its own.
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.
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 | — |
https://510kreport.com/device/K001775 · printed Nov 6, 2026
Cite this page
510(k) Report. “K001775: Zoe Medical Nightingale Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K001775
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026