510(k) · Cleared
ClearedNeo-Servo I
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Atom Medical Corporation · FMZ Incubator, Neonatal
Cleared on Dec 22, 2010 as substantially equivalent to K061856 (Atom Medical, Inc., 2006) after a 93-day review. Its family tree reaches back 4 generations to 1997. 1 later device descends from it.
- Decided
- Dec 22, 2010
- Review
- 93 days
- Class
- Class II
- Product code
- FMZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K962603 (1997). 6 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 3 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
- 2 generations backK990966 Masimo Set 2000 Pulse Oximeter, Masimo Lnop -Adt-Adult/Pediatric…Masimo Corp. · 1999
- 1 generation backK061856 V-2200 Infant IncubatorAtom Medical, Inc. · 2006
- This deviceK102710 Neo-Servo IAtom Medical Corporation · 2010
- Descendant · cites it directly · 0 of its ownK132543 Infant IncubatorBistos Co., Ltd. · 2014
Most influential descendants
Showing 1 of 1 · See all- K132543Infant IncubatorBistos Co., Ltd. · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables | Masimo Corp. | 1997 | — |
| −3 | K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables | Masimo Corp. | 1998 | — |
| −2 | K990966 | Masimo Set 2000 Pulse Oximeter, Masimo Lnop -Adt-Adult/Pediatric Disposable… | Masimo Corp. | 1999 | — |
| −1 | K061856 | V-2200 Infant Incubator | Atom Medical, Inc. | 2006 | — |
| 0 (this device) | K102710 | Neo-Servo I | Atom Medical Corporation | 2010 | — |
| +1 | K132543 | Infant Incubator | Bistos Co., Ltd. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 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 FMZ? 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 FMZ device
- #1 K251663 Giraffe OmniBed Carestation (CS1); Giraffe…score 14.4 · 5 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 |
|---|---|---|---|
| * | K061856 | V-2200 Infant IncubatorSummary page 1…CER 880.5400 Device: Neo-Servo i Atom Infant Incubator Model 102 Predicate Devices: Atom Model V-2200 - K06 1856 Device Description: The Neo-Servo i Atom Infant incubator Model 102 consists of a hood, a main body, a control panel and is offe… | 2006 |
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 |
|---|---|---|---|
| K132543 | Infant Incubator | 2014 | 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?
- The line of descent spans 13 years and passes through 3 companies; a new generation was cleared every 4.2 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K132543 (Bistos Co., Ltd., 2014) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K061856.
How does its category compare?
All FMZ devicesFMZ Incubator, Neonatal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · FMZ
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FMZ
60in 2010
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FMZ
2in 2024
Class I (11 since 2007) Class II/III not classified
Adverse event reports per year · FMZ
250in 2025
MAUDE reports naming product code FMZ, 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 | 3 | 81 | 0 | 14 |
| 2008 | 1 | — | 4 | 10 |
| 2009 | 0 | — | 0 | 8 |
| 2010 | 4 | 60 | 0 | 11 |
| 2011 | 1 | — | 5 | 10 |
| 2012 | 0 | — | 0 | 12 |
| 2013 | 0 | — | 1 (1) | 11 |
| 2014 | 1 | — | 0 | 3 |
| 2015 | 1 | — | 0 | 9 |
| 2016 | 1 | — | 1 | 12 |
| 2017 | 1 | — | 0 | 4 |
| 2018 | 2 | — | 3 | 18 |
| 2019 | 2 | — | 1 | 24 |
| 2020 | 0 | — | 0 | 8 |
| 2021 | 0 | — | 0 | 15 |
| 2022 | 1 | — | 0 | 27 |
| 2023 | 0 | — | 8 (8) | 19 |
| 2024 | 0 | — | 2 (2) | 118 |
| 2025 | 2 | — | 0 | 250 |
| 2026 | 2 | — | 3 | — |
What is it indicated for?
The Neo-Servo i Atom Infant Incubator Model 102 is a closed-type incubator for
newborns and premature neonates. It is mainly intended for temperature control in
neonatal hypothermia, observation and examination in newborn nurseries, prevention of
body temperature drop shortly after delivery, and pre-operative and post-operative
intensive care in neonatal surgery. The incubator is provided with a function to control
the infant's skin temperature.
Environment of use - Hospitals, delivery suites, NICU
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102710 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102710: Neo-Servo I.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102710
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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